Center for Devices and Radiological Health Health Hazard Evaluation Health Risk Assessment El RES ORACLE RECALL (5): Date: August 19, 2011 Safety Of?cer: John Diehl LKK Device Name: II Implantable Infusion Pump Model: Lot/Serial Numbers: Model 8637-20 and 3637-40 Marketing Status (Include or PMA Number, Specify if Exempt From 51000 Total Number of Devices in Distribution: 139,653 U.S.: 105,002 Foreign: 34,651 Number of Devices Subject to Review: U.S.: 105,002 I Foreign: 34,651 Manufacturer Address: MDT Puerto Rico Operations (30., Iuncos Road #31, km.24, hm 4 Ceiba Norte Industrial Park, Iuncos, Puerto Rico 00777 Parent Company Medtronic, Inc Neuromodulation 7000 Central Ave NE Minneapolis, Minnesota 55432?3 568 T: 763-526-9738 F: 651-367-0814 FEI: 2182207 Product Description (Include Intended Use from labeling or known off-label uses): The Implantable Infusion System is an implantable programmable infusion pump used to deliver morphine sulfate, ziconotide and Lioresal for the treatment of chronic pain, severe chronic pain and severe spasticity, respectively. The Implantable Infusion System is also indicated for delivery of ?oxuridine and methotrexate for the treatment of primary or metastatic cancer. By use of a sterile syringe and needle, the drug is injected into the pump reservoir through the re?ll septum. The physician uses an external programmer to program the infusion rate prescription). The prOpellant within the pump provides pressure which pushes on the drug reservoir, causing the drug to flow through the internal bacterial ?lter into the internal pump tubing. A three-pronged pump head roller assembly rotates at a Speed commensurate with the physician-programmed dose, which controls the drug infusion rate exiting the pump via the catheter connector. The II Pump is supplied inl20 ml and 40 ml reservoir sizes. In the United States, the II Pump is indicated when patient therapy requires chronic infusion of speci?c drugs. Page 1 Center for Devices and Radiological Health Health Hazard Evaluation Health Risk Assessment El RES 59317 ORACLE RECALL it (5): Date: August 19, 2011 Safety Of?cer: John Diehl '1 Weigh . we-.-ulnoh.. .n 0 Description of the Defect, Malfunction or Error in Use of the Device: According to the FDA Investigator (Investigator), battery resistivity can lead to low battery reset and pre-mature early replacement indicator (BRI). Low battery re?set can lead to pump failing to infuse. Drugs such as Baclofen cannot be abruptly stopped due to risk of death. According to the ?rm, pumps were returned from the ?eld after exhibiting low battery reset and premature ERI. The II battery part number (W4) speci?cation states the (W4) . - 3(bJ(4) Real time testing of (WW batteries by the Medtronic battery supplier revealed that the resistance was exceeding (biwohms in fgzbatteries. According to Medtronic report . (b . . (hilt!) (W4) 0 Root Cause of the Problem (If Known) According to the investigator, resistive film develops between cathode pellet and cathode current collector. The physical cause of the ?lm is not yet known by the ?rm. According to the ?rm, . -- (bll4) has been identi?ed as the source of battery drop voltage during high current demands. A (bim?lm forms on the cathode surface. Of all battery cells studied, this resistance ?lm was seen. The . (W4) ?lm may cause variations in the battery voltage that can prematurely activate the pump ERI, end of service, and/or cause a low battery reset. 0 Factors that May Contribute to Product Risk Device Design, Manufacturing Problems or User Error): According to the investigator, design of battery and manufacturing variability in battery manufacturing According to the ?rm, the root cause pertaining to why the resistive ?lm forms in battery cells is unknown. 0 If Device Failure Occurs is it Easily Recognized by User? Users may not recognize a device failure until the device has failed and they begin to experience clinical consistent with termination of therapy. However, sudden cessation of intrathecal baclofen may result in serious injury and death. Oral Baclofen may be effective in preventing serious injuries or death. A Functional alarm may alert users to device failure prior occur, however it is unknown at this time whether this failure may cause the alarm to fail. According to the ?rm, the reduced battery performance issue could manifest itself clinically as a return of underlying withdrawal and the potential for complications due to withdrawal. OCHHEF125.047 Page 2 Center for Devices and Radiological Health Health Hazard Evaluation El Health Risk Assessment CI RES a: __59317 ORACLE RECALL a (5): Date: August 19, 2011 Safety Officer: John Diehl Manufacturer?s CAPA Investigation (If Available): Summary: According to the ?rm, as of May 2009, they had identi?ed nine 11 drug pumps that were returned from the ?eld a?er exhibiting low battery reset and premature Elective Replacement Indicator (ERI). These devices were analyzed and found to be experiencing reduced battery performance, which occurred after (bli?ilmonths of implant duration. The anticipated battery life for II pumps is seven years (84 months). Engineering analysis indicated that the reduced battery performance was due to over time. The 1W4) may cause variations in battery voltage that can prematurely activate the pumps bKl, 13nd of Service (1308), and/or cause a Low Battery Reset. This reduced battery performance issue could manifest itself clinically as a return of underlying withdrawal and the potential for complications due to withdrawal. Testing of batteries from ?eld returns, as well as production lifetest samples indicates that some batteries of this design can experience elevated resistance that can result in premature ERI or unacceptably low supply voltage during high current demands. Date of Analysis: HHA initiated by ?rm on November 10, 2008, and completed on June 16, 2009. CAPA 1550 opened by ?rm on September 12, 2008 *Update to May 2011 According to the ?rmthey have con?rmed that 55 11 drug pumps were returned from the ?eld worldwide after exhibiting low battery reset and/or premature ERI. These devices were analyzed by the firm and found to be experiencing reduced battery performance, which occurred between (W4) months implant duration. As stated previously, the anticipated battery life for ll pumps is 84 months. All but one of the reports occurred in pumps that were included in the affected pepulation for the 2009 recall (Le. they were built with batteries manufactured prior to March 17, 2005). Firm?s Estimate of Number of Devices that will develop the Defect and/or Fail: According to ?rm, based on survival analysis of the implant duration of the suspect pepulation, the estimated proportion of devices that may fail by ?ve years post implant is Based on reliability modeling of the affected batteries, Medtronic estimates that up to of the suspect population may be at risk for this battery mode failure. 0 How Many Devices from the Affected Lots Are Expected to Have or Develop the Defect? Between August 15, 2003, and March 16. 20053 the worldwide population of active implanted pumps with batteries subject to resistivity issues was (hm . All of these lots could develop the defect. - How Many Devices with the Defect are Likely to Exhibit the Failure over the Lifetime of the Device? The ?rm estimated that only 1b)(4)of these 14,852 pumps were likely to exhibit this failure. 0 Of Those Devices that Fail, How many are Likely to Cause Injury if Used? Of the pumps the ?rm estimated to fail: (MM) 0 011(4) *Update to May 2011 Pumps with batteries manufactured prior to March 17, 2005statistical analysis of the con?rmed cases has estimated the cumulative probability for pump failure due to this issue to be (mmat 84 months post implant with an upper bound estimate of (W4) Note that this :umulative probability applies to a patient newly implanted, and re?ects the risk over the full 7 years of expected pump life. The majority of pumps currently OCHHEF125.047 Page 3 Center for Devices and Radiological Health Health Hazard Evaluation Health Risk Assessment El RES 59317 ORACLE RECALL (8): Date: August 19, 2011 Safety Of?cer: John Diehl implanted were manufactured 6 years ago and therefore the probability for pump failure between now and end of service life is less than (bll?il These rates are within the overall rates estimated in the July 2009 communication. Pumps with batteries manufactured on or after March 17, 2005: As of May 31, 2011, statistical analysis of the con?rmed case has estimated the cumulative probability for pump failure due to this issue to be I (9X4). at 72 months post implant with an upper bound estimate of (W4) I Firm?s Conclusion about Health Risk (Attach a Copy of Firm?s HHEs or HHAs): According to the ?rm, . ..--.- - . . 1? . More details are included in the ?rm?s I-II-IA. In July 2009, the firm issued an Urgent Medical Device Correction to make health professionals aware of the battery performance issues with the II pumps. Also, in CAPA 1550, the ?rm concluded that the elevated resistance values 020(4) were not a predictor of pump performance. The firm wrote a deviation (him) to allow batteries to exceed (bll4l3peei?cation. The firm was not able to discover the underlying cause of the high resistance in batteries and the physical cause of the resistive ?lm that develops within the battery is still not known. *Update to May 201 Beginning July 5, 2011, the ?rm began mailing physicians (based on registration data for the II pump) a letter that contained updated information regarding the scope and occurrence of this battery performance issue, and that emphasized previously communicated patient management recommendations. The ?rm made it clear in their communication that Patients receiving intrathecal baclofen therapy are at risk for baclofen withdrawal which can lead to a life threatening condition if not and effectively treated. This issue is being treated as a Class I recall by the ?rm. I Any FDA Comments: FDA has concerns with the ?rms risk assessment, including estimates of failure rate. For example, the ?rm estimated that (bll?llof affected pumps will exhibit this failure, however lbll4bf the batteries tested failed. The ?rm has not provided CDRH with data to determine whether resistivity issues will develop in battery production lots manufactured after December 2006 because it takes time for the resistive film to develop between the cathode pellet and the cathode current collector. The ?rm continues to manufacture and distribute pumps with these defective batteries. The FDA is concerned that if the pump resets to a default value that the pump may not notify the user that this is occurring. Also, the FDA has concerns with the firms statement that these pump failures will begin to occur after (him months of use as they have not provided data supporting this claim. The ?rm should provide data to support their claim that the pump may fail between (him months and not sooner. The ?rm has submitted a PMA supplement to CDRH for the re?design of the II battery, but, as of the investigators April 3, 201 1 request, this supplement has not been approved. Currently, FDA is reviewing the ?rm ?3 re- designed battery submission and there are concerns that the pump alarm may not work properly when or if the battery fails. If the pump were to have a short circuit (either an battery internal short or an external component that causes the battery terminals to short-circuit) that does not reCOVer, there would be no voltage available to sound an alarm or, if the alarm system fails as a result of a component failure, the pump system continues to operate normally, however the alarm system is no longer noti?es the patient (or care giver) if the battery fails and pump resets. This does not satisfy the requirements of the single fault safe condition required by EN 455 02?1 1998 clause 19.3. Does the pump have a backup alarm system? If the pump?s alarm circuit is not functioning, how will the patient/caregiver be noti?ed? FDA will continue to review the firm?s supplement for the re-design of the ll battery. OCHHEF125.047 Page 4 Center for Devices and Radiological Health Health Hazard Evaluation Health Risk Assessment El RES 59317 ORACLE RECALL Date: August 19, 2011 Safety Of?cer: John Diehl *Update to May 2011 The ?rm?s PMA supplement for the re-design of the II battery was approved by FDA on July 1, 201 1. Adverse Events, Complaints and Problems or Incidents that may be related to the Device Defect: Number of Complaints 507 Malfunction Reports Injuries Reported U.S. International Deaths Reported US. *9 International *It can not be de?nitively determined how many deaths were attributed to the battery resistivity issue. Please refer to the PAER analysis provided by OSB as two separate MAUDE searches were conducted. Sources: Manufacturer Inspection 52 Explanation: According to the investigator, Medtronic Puerto Rico Operations Company in Juncos, Puerto Rico assembles the ?nished II Infusion Pump device. All information regarding returned device analysis, MDR ?ling, etc is maintained at Medtronic Neuromodulation, 7000 Central Ave NE, mailstOp RCC150, Minneapolis, Minnesota 55432. Per the OSB PABR: The ?rst search of the MAUDE database was conducted using the following criteria: the date entered between August 1, 2009, and April 26, 2011; product codes LKK and manufacturer short name. This search generated a total of 6,754 MDRs. Then, a text search was conducted using the term ?battery?. This resulted in 381 MDRs. Types of events were reported as: 8 deaths, 230 injuries, and 143 malfunctions. Of these, 61 reports or 8.57% utilized a device problem code of ?low battery? and an additional 31 reports or 4.22% utilized a device problem code of ?battery issue?. A second search of the MAUDE database was conducted using the recall number Z-2276-2009. This resulted in 74 MDRs. Types of events were reported as: 1 death, 43 injuries, and 30 malfunctions. Of these, 9 reports or 7.38% utilized a device problem code of ?low battery,? and an additional 13 reports or 10.66% utilized a device problem code of ?battery issue.? Please note that multiple device codes may be reported in each MDR, and therefore the total number of problem codes may exceed the number of MDRs. The FDA is concerned that the MDR reports attributed to this issue may be underreported because the ?rm has a history of reporting adverse events to CDER instead of CDRH. OCI-IHEF125.047 Page 5 Center for Devices and Radiological Health Health Hazard Evaluation Health Risk Assessment El RES S9317 ORACLE RECALL Date: August 19, 2011 Safety Officer: John Diehl Describe the Complaints and Injuries Reported to Date: According to the investigator, per CDRH and OSB request, the inspectional team was asked to review MDR 3007566237- 2010-07017 regarding a patient death (Baclofen patient) whose pump was found to have a high battery resistivity and was in a low-battery reset mode. - Per the PAER completed: RE: Patient Death Reports General Event Description and Additional Notes Information MDR It was reported that the pt underwent elective pump replacement; the pump was replaced 3007566237?2010- due to a "low battery condition (alarm was generated Following the replacement, the pt 04748 was admitted to the intensive care unit for 10 days and died of a suspected sudden cardiac arrest. It was noted that "pump diagnostics post-operativer had all been satisfactory". At autopsy, it was noted that "the catheter was divided cleanly in two in the pump pocket". 11 The presumption was that this was perioperative though this hadn't been de?nitely Model: 8637 established. The investigation was ongoing. It was unk if the devices contributed to the pt's death. The device system was used to deliver Baclofen. Add'l info has been requested. A follow-up report will be sent if add'l info becomes available. General Event Description and Additional Notes Information MDR The pump was re?lled Thursday 8/19/2010 with Baclofen 2,000mcg/ml and set at a dose 3007566237-2010- of 12.5mcg/day. Late the following Saturday the patient awoke screaming in pain and his 07017 mother gave him 20mg oral Baclofen and soma. He awoke in pain again at 5:30am Sunday and was given an additional 20mg of oral Baclofen; the paramedics were called. They arrived at 8:00am Sunday and transported the patient to the emergency department. The 11, Model: 863740 patient arrived unresponsive and with a temperature of 109. He was pronounced dead at Serial Number: 9:30am that day. The medical examiner believed Baclofen withdrawal was a possible NGV003562N cause of death. Telemetry strips correlating to pump examination on 8/27/2010 indicated that the pump had reset and was in safe state. Analysis results were pending. Supplement report indicated: Final device analysis of the pump revealed battery resistance high. Final device analysis of the returned catheter segments revealed no signi?cant anomalies; acceptable catheter testing. An additional information request was generated to the ?rm. Please see PAER for details. OCHI-IEF125.047 page 6 Center for Devices and Radiological Health Health Hazard Evaluation El Health Risk Assessment El RES 59317 ORACLE RECALL Date: August 19, 2011 Safety Officer: John Diehl *Update to May 2011 According to the ?rm, there are 55 reports associated with primary ?nding or low battery reset or premature BRI as con?rmed by Medtronic: Any of the following terms or conditions Qualitative Total reported: Severity Reports Death Death 1 Intensive care treatment, extended Life Threatening 8 hOSpitalization, exaggerated rebound spasticity, altered mental state Return of Underlying medical Serious Injury 46 intervention, surgical revision ore observation and none of terms for severity 4 Adverse events reported, but no medical Non-Serious intervention Injury Report of battery issue, but no adverse No Injury 0 reported Total 55 A listing of the MDR report numbers that have been reported is included in Medtronic?s HHA (ref: NDHF1119-102866). Two MDR numbers were not available at the time the HHA was written, these are listed below: PCR 553508: 3007566237201104752 PCR 555341: 3007566237201104517 page 7 Center for Devices and Radiological Health Health Hazard Evaluation IZI Health Risk Assessment El RES 59317 ORACLE RECALL (5): Date: August 19, 2011 Safety Of?cer: John Diehl ?4 1 .. . THE FOLLOWING ASED ON CURRENTL ATION. CONCLUSIONS MAY CHANGE IF ADDITIONAL INFORMATION BECOMES AVAILABLE IN THE FUTURE. Immediate and Long Range Health Consequences: A. Describe the Immediate and Long Range Health Consequences (Injuries or Illnesses) That May Result from Use of or Exposure to the Defective Device. (Include Known Off Label Uses) Use of a defective device may result in underdosing or abrupt cessation of therapy. The health consequences due to underdosing or abrupt cessation of therapy may include rebound pain, return of Spasticity and delay of therapy. Abrupt withdrawal of Baclofen can lead to rebound spasticity, seizures, fever, multi-organ system failure and death. When this failure occurs, patients will require additional surgery and anesthesia to replace the device, exposing patients to the risks associated with surgery and anesthesia, and may include serious injuries or death. B. Describe Any Factors That May Mitigate the Risk: Immediate recognition of withdrawal and/or device alarm by the user may mitigate the risk associated with use of this defective product. C. What Segment of the Population is Most at Risk? Infants, Elderly, Pregnant Women, Critically Ill Patients, Immunocompromised, etc.) Elderly, Critically ill, Patients on Baclofen D. Does the Health Consequence Have Signi?cant Public Health Impact Beyond Users Spread of Serious Infection to Others)? No Assess the Hazards Associated with Use of the Defective Product When failure of the battery occurs, it will require surgery to replace the battery. Check All that Might Occur: Population at Overall Population Greatest Risk Using Device g] IE Life-threatening (death has or could occur) Results in permanent impairment of body function or permanent damage to a body structure. VA Necessitates medical or surgical intervention. Temporary or reversible (without medical intervention). El Limited (transient, minor impairment or complaints). No adverse health consequences. Explanation: OCHHEF125.047 page 8 Center for Devices and Radiological Health Health Hazard Evaluation IZI Health Risk Assessment El RES 59317 ORACLE RECALL (5): Date: August 19, 2011 Safety Of?cer: John Diehl Serious Adverse Health Consequences or Death Overall Population Using Device Population 31' Greates" Reasonable Probability 13 El Remote Probability El Not Likely Explanation I Comments: B. Temporaryr or Medically Reversible Adverse Health Consequences Overall Population Using Device Population at Greatest Risk May Cause g] ,3 Not Likely to Cause I: Explanation Comments: Center for Devices and Radiological Health Health Hazard Evaluation Health Risk Assessment El RES 573/1 ORACLE RECALL (8): Date: August 19, 2011 Safety Of?cer: John Diehl Signatures Printed Namg Title and Of?ce W24 ,0 0mm Page 10 Medical Radiation Emitting Device Recalls Page 1 of 1 U.S. Food Drug Administration Medid'l 8: Radiation Emittinq Device Recalls 0 :31 FDA Home3 ?edical Devices?l Databases5 6 . (a 5 LislingelAdverse CFR Title 21 ?Radiation-Emitting AssemblerialMedsun New Search Back to Search Results Class 1 Recall Medtronic 3% tests in Date Posted August 29. 2011 Recall Number 2-3043-2011 Product Medtronic ll. Model 8637. (The Pump is supplied in 20 ml or 40 ml reservoir size.) Sterilized using ethylene oxide. The pump is part of an infusion system that stores and delivers a prescribed drug to a speci?c site. The implantable components of the l Infusion System include the pump. catheter. and catheter accessories. serial numbers: thru NGP002152R, NGP000565N thru NGP034132N. thru NGP350081H, thru . NGP350094H thru NGP350414H, NGP350416H. NGP350417H, NGP350418H, NGP350419H. NGP350421H. NGP350422H. NGP350423H. NGP350424H. NGP350425H, NGP350427H. NGP350428H. NGP350431H thru NGP350466H, NGP350468H thru NGP350506H, NGP350509H thru NGP350576H. NGP350578H, NGP350579H. NGP350580H. NGP350532H. NGP350583H. NGP350585H thru NGP350601H. NGP350602H. NGP350603H. NGP350604H. NGP350606H thru NGP350814H. NGP350815H thru NGP350837H, thru NGP350852H. NGP350860H thru NGP350680H. NGP350882H thru thru NGP350916H, NGP350918H thru NGP351199H thru NGP351229H. NGP351231H thru NGP351258H, NGP351260H thru NGP351302H, thru NGP351337H. NGP351339H thru NGP351396H. NGP351398H thru NGP351456H, NGP351458H. NGP351459H, NGP351460H, NGP351465H. NGP351467H thru NGP351497H. NGP351499H thru NGP351501H. NGP351603H thru NGP351617H. NGP351619H thru NGP351651H. NGP351653H. NGP351654H, NGP351655H thru NGP351800H. NGP351802H thru NGP351809H, NGP351811H thru NGP351826H thru NGP351863H. NGP351865H, NGP351868H thru NGP351904H. NGP351905H thru NGP351921H thru NGP351996H. NGP351998H. NGP351999H, NGP352000H. NGP352002H. NGP352003H. NGP352004H, NGP352005H, NGP352007H. NGP352009H thru NGP352149H, NGP352151H thru NGP352221H, NGP352223H thru NGP352250H. NGP352252H thru NGP352279H. NGP352281H thru NGP352403H. NGP352405H thru NGP352417H. NGP352419H thru NGP352442H. NGP352444H NGP352473H, NGP352475H. NGP352476H. NGP352477H. NGP352478H. NGP352480H thru NGP352548H. NGP352550H thru NGP352558H. NGP352560H. NGP352561H. NGP352562H. NGP352564H thru NGP352756H. NGP352758H thru NGP352778H, NGP352780H thru NGP352896H. NGP352893H thru NGP352918H. thru NGP353016H. NGP353018H thru NGP353085H. NGP353087H thru NGP353252H. NGP353254H thru NGP353296H. NGP353298H. NGP353299H. NGP353300H. NGP353301H. NGP353303H. NGP353304H, NGP353305H. NGP353306H, thru NGP353364H. NGP353356H. NGP353367H, NGP353368H, NGP353359H, NGP353371H thru NGP353477H. NGP353479H. NGP353480H, NGP353481H. NGP353484H thru NGP353505H. NGP353507H thru NGP353533H thru NGP353599H. NGP353601H thru NGP353637H. NGP353639H. NGP353640H. NGP353641H. NGP353643H, NGP353644H. NGP353645H. NGP353646H, NGP353647H. NGP353648H, NGP353649H. NGP353551H thru NGP353666H thru thru NGP353752H. NGP353753H. NGP353754H. NGP353755H. NGP353756H. NGP353757H. NGP353758H. NGP353759H, NGP353760H, NGP353761H. NGP353763H thru NGP353789H. NGP353791H thru NGP353823H, NGP353824H. NGP353827H. NGP353828H. NGP353830H. NGP353832H thru NGP353923H. thru NGP353947H. NGP353949H. NGP353951H. Code lnfonnation NGP353952H. NGP353953H. NGP353956H NGP353959H NGP353966H NGP353972H NGP353979H NGP353986H NGP353992H NGP354000H . NGP353960H. . NGP353967H. NGP353973H, . NGP3539BUH. . . NGP353993H. NG P3 53961 H. NGP353968H, NGP353974H. NGP353981 NGP353988H NGP353994H, NGP354003H. NGP353962H NGP353969H .NGP353957H, .NGP353964H, . NGP353970H, NGP353976H, . NGP353989H. NGP353995H. NGP354004H, NGP353984H. NGP353990H. NGP353996H. NGP354005H. NGP353965H, NGP353971 H, NGP35397BH, NGP353985H, NGP35 3991 H. NGP353999H, NGP354006H, 3/21/2013 Medical Radiation Emitting Device Recalls NGP354010H thru NGP354031H, NGP354034H. NGP354035H. NGP354036H. NGP354037H. NGP354039H, NGP354D4OH. NGP354042H. NGP354D43H, NGP354044H. NGP354045H, NGP354046H, NGP354047H, NGP354048H. NGP354050H thru NGP354084H, NGP354086H [hm NGP354174H, NGP354176H thru NGP354227H. NGP354229H thru NGP354236H. NGP354238H thru NGP354330H. NGP354332H thru NGP354343H, NGP354345H NGP354392H NGP354400H NGP354406H NGP354413H NGP354488H NGP354533H NGP354542H NGP354552H NGP354568H NGP354575H . .NGP354401H, .NGP354414H. .NGP354489H. .NGP354534H. . NGP354545H. . NGP35457OH. NGP354577H. NGP354347H. NGP354348H. NGP354349H. NGP354351H thru NGP354395H, NGP354396H. NGP354397H. NGP354399H. NGP354402H. NGP354403H, NGP354404H. NGP354405H. NGP3544OBH. NGP354409H. NGP354411H. NGP354412H. NGP354419H thru NGP354486H, NGP354491 thru NGP354526H, NGP354531 H. NGP354535H, NGP354537H. NGP354540H. NGP354541H. NGP354547H. NGP354548H. NGP354549H. NGP354551H. NGP354555H. NGP354556H. NGP354557H, NGP354571H. NGP354572H. NGP354573H. NGP354574H. NGP354586H. NGP354588H thru NGP354599H, NGP354601H NGP354616H. NGP354618H. NGP354621H thru NGP354648H. NGP354649H, NGP354550H, NGP354651H. NGP354652H. NGP354653H. NGP354654H. NGP354655H, NGP354657H. NGP354658H. NGP354659H NGP354677H NGP354744H NGP354861 NGP354867H NGP354934H NGP354940H NGP354947H . NGP354670H NGP354745H . NGP354862H NGP354858H . NGP354875H . NGP354881 . NGP354887H . NGP354935H . NGP354941 NGP35494BH . NGP354663H, NGP354656H, NGP354657H, NGP354668H, . NGP354672H. NGP354673H. NGP354674H. NGP354675H. NGP354682H. NGP354684H. NGP354687H thru thru NGP354805H. NGP354807H thru NGP354858H. NGP354860H. . NGP354863H, NGP354865H. . NGP354859H, NGP354870H, NGP354872H. NGP354873H. . NGP354876H. NGP354877H, NGP354878H, . NGP354882H. NGP354883H. NGP354884H. NGP354885H, . NGP354889H thru NGP354929H, NGP354931H. . NGP354936H. NGP354937H. NGP354938H, NGP354939H. . NGP354943H, NGP354944H. NGP354945H. NGP354946H. . NGP354949H. NGP354950H. NGP354952H. NGP354954H thru NGP355002H. NGP355003H, NGP355004H. NGP355007H NGP3550 33H NGP355034H NGP355056H, NGP355058H. NGP355171H. NGP355173H. NGP355179H, NGP355186H, NGP355187H. NGP355194H. NGP355201H, NGP355202H. NGP355210H. NGP355211H. NGP355215H. NGP355217H, NG P3552 25H, NGP355226H NGP355232H. NGP355233H NGP355020H. . NGP355042H. NGP355059H. NGP355174H. NGP355181H. NGP355188H. NGP355195H. NGP355204H. NGP355212H. NGP355220H. . NGP355227H. NGP355234H, NGP355239H. NGP355241H thru NGP355260H. NGP355262H thru NGP355287H, NGP355289H NGPB55023H, NGP355043H. NGP355060H. NGP355175H. NGP355190H. NGP355197H. NGP355205H. NGP355213H, NGP355221 H. NGP 355 236H. NGP355027H, NGP355050H, NGP355061H. NGP355177H. NGP355184H, NGP355191H, NGP355199H. NGP355207H. NGP355214H, NGP355222H. NGP355230H. NGP355237H. NGP355051 H. NGP355064H thru NGP355178H. NGP355185H. NGP355192H. NGP355200H. NGP355209H. NGP355215H. NGP355231H. NGP355238H. thru NGP3553OBH. thru NGP355319H, thru NGP355357H. NGP355359H thru NGP355374H. NGP355375H thru NGP355397H. NGP355399H, NGP355401H, NGP355402H. NGP355403H, NGP3554D4H. NGP355405H. NGP35540TH. NGP355408H. NGP355409H, NGP355417H, NGP355419H. NGP355420H. NGP355421H. NGP355422H. NGP355423H. NGP355425H thru NGP355450H, NGP355462H thru NGP355495H. NGP355497H, NGP355498H. NGP355502H thru NGP355522H, NGP355524H thru NGP355630H. NGP355647H. NGP355665H. NGP355679H. NGP355594H. NGP355727H. . NGP355737H. NGP355747H. NGP355756H, NGP355767H. NGP355773H. NGP355787H. NGP355818H, NGP355841H. NGP355853H. . NGP355875H. NGP355890H, . NGP355896H. NGP355499H, NGP3555 33H . NGP355654H. NGP355668H, NGP355684H. NGP355719H. NGP35573OH. NGP355741H. NGP355758H. NGP355769H. NGP355808H, NGP355825H. NGP355846H. NGP355860H. NGP355884H. NGP355892H, NGP355898H, NGP355907H. NGP355914H. NGP355920H. NGP355929H. 59 38H I NGP355944H, NGP355965H, NGP355500H. NGP355634H, NGP355656H. NGP355671 H. NGP355689H, NGP355721H, NGP355731H. NGP355742H. NGP355753H. NGP355759H NGP355848H NGP355863H, NGP355886H NGP355893H, NGP355974H NGP355773H NGP 35 5783H NGP355811H 3H NGP355916H NGP355922H NGP355946H NGP355967H NGP355640H, NGP355653H. NGP355673H. NGP355691 H. NGP355722H. NGP355732H, NGP355743H, NGP355754H, . NGP355760H. NGP355771H. NGP355782H. NGP355830H. NGP355643H. H. NGP355676H. NGP355725H. NGP355745H. NGP3 55751 H. . NGP355786H. NGP355812H. NGP35585OH, NGP355869H. .NGP355887H. NGP355894H. NGP355901H, . NGP355909H, NGP355915H, N69355921H, NGP355930H, NGP355939H. NGP355945H, NGP355965H. NGP355874H NGP355388H. NGP355895H NGP355902H. NGP355910H, .NGP355917H, NGP355940H. NGP355934H, NGP355941H. NGP355903H 35 5935H NGP355653H. NGP355666H. NGP355680H. NGP355697H, NGP355728H, NGP355739H. NGP355749H. NGP355757H. NGP355768H. NGP355780H, NG 94H, NGP355822H. NGP355843H, NG9355876H. NGP 35 5891 H. NGP3558 97H . NGP355906H. NGP35591 1 H. NGP355918H. NGP355924H. .NGP355937H. . NGP355948H 1hru NGP355962H. NGP355964H. . NGP355968H. NGP355969H, NGP355971H. .NGP355975H. NGP355913H, NGP355919H. NGP355926H. NG P3 55943H, NGP355976H. NGP355977H. NGP355979H. Page 2 ofll 3/21/2013 Medical Radiation Emitting Device Recalls Page 3 of 11 NGP355980H. NGP356007H. NGP355013H. NGP356037H, NGP356051H. NGP356059H. NGP356072H, NGP356079H. NGP355085H. NGP356092H, NGP356107H, NGP356115H. NGP356124H, NGP356133H, NGP356145H, NGP356157H. NGP355170H. NGP356224H. NGP35631 1H. NGP356330H, NGP355338H. NGP356344H. NGP356352H, NGP356359H. NGP356368H, NGP355982H thru NGP356002H, NGP356004H, NGP356005H. NGP355006H. NGP356008H, NGP356009H. NGP355010H, NGP356011H, NGP356012H. NGP356015H. NGP355016H. NGP356018H lhru NGP356035H, NGP356038H, NGP356042H. NGP356044H, NGP356046H. NGP356053H. NGP356054H. NGP356056H. NGP356060H, NGP356051H. NGP356062H, NGP356053H, NGP356054H. NGP356056H. NGP356067H. NGP356071H, NGP356073H. NGP356074H. NGP356075H. NGP356076H. NGP35607BH. NGP356031H. NGP356082H, NGP356083H. NGP356084H. NGP355087H. NGP356089H. NGP356091H. NGP356094H, NGP356096H. NGP356104H, NGP356105H. NGP356106H. NGP3551OBH, NGP356109H. NGP356110H, NGP356114H. NGP356118H. NGP356119H. NG9356121H.NGP356123H. NGP356126H. NGP356127H. NGP356129H. NGP356130H. NGP356135H. NGP356137H. NGP356143H. NGP356144H. NGP355146H, NGP356147H. NGP356150H, NGP356156H. NGP356158H, NGP356159H. NGP356161H. NGP356163H. NGP355167H, NGP356171H, NGP356172H, NGP356175H, NGP356175H, NGP356178H. NGP356232H lhru NGP355304H. NGP356305H. NGP356307H. NGP356312H. NGP355313H. NGP356315H lhru NGP356327H. NGP356329H, NGP356331H, NGP356332H, NGP356335H, NGP356337H. NGP356339H, NGP356340H, NGP356341H, NGP356342H, NGP356343H, NGP355347H. NGP356349H, NGP356350H. NGP356351H. NGP356353H, NGP356354H, NGP356355H, NGP356356H, NGP356357H. NGP356361H. NGP356362H, NGP355364H. NGP356365H, NGP356389H. NGP35637UH. NGP356372H. NGP356375H NGP356382H NGP356390H NGP356402H NGP356418H NGP356424 NGP356436H NGP356449H NGP356457H NGP356496H NGP35651 2H NGP356532H NGP356552H NGP356569H NGP356581 NGP356631 NGP356643H NGP356652H NGP356662H NGP356673H NGP356684H NGP356700H NGP356374H. 381 H. NGP356389H. NGP356400H. NGP356417H. NGP356423H. NGP356435H, NGP356448H. 56H. NGP356493H. NGP356508H. NGP356547H, NGP356568H. NGP3 56 580H. NGP356630H. NGP356642H. NGP356651H. NGP356672H, NGP356699H, NGP356376H, . NGP356383H. . NGP356391H, . NGP356405H. . NGP355426H, . NGP356439H. . NGP356459H, . NGP356498H, .NGP356513H. . . NGP356553H. . . NGP356582H. . NGP356632H. . NGP356645H, . NGP356653H. . NGP356664H. . . NGP356685H, . NGP356706H. . NGP356728H, NGP356377H. NGP356378H. NGP356386H. NGP356387H. NGP355394H, NGP356396H. NGP356408H. NGP355409H. NGP355420H, NGP356421H, NGP355432H, NGP355433H. NGP35644DH. NGP356443H. NGP3SB451H, NGP356453H. NGP356464H thru NGP355489H. NGP356492H. NGP356499H, NGP356516H. NGP356521H. NGP356535H. NGP356536H. NGP356564H. NGP356565H, NGP356576H. NGP356578H, NGP356603H. NGP356637H. NGP356639H. NGP355646H. NGP356647H, NGP355656H. NGP356657H, NGP356668H. NGP356659H. NGP356676H. NGP356678H. NGP356686H. NGP3567U7H. NGP35671 1 H. NGP356731H, NGP356734H, NGP356379H. NGP 356397 H, NGP356411H. NGP356422H. NGP3564 34H. NGP356447H. NGP356455H. NGP356507H. NGP356524H. NGP356542H. NGP356566H, NGP356579H. NGP355605H. NG P355641 H. NGP356548H. NGP356560H. NGP356571H. NGP356680H. NGP356692H. NG P3 567 14H. NGP3567 36H. NGP356737H. NGP356770H. NGP356739H thru NGP356765H. NGP356767H, NGP356768H. NGP356769H, NGP356771H. NGP356773H thru NGP356809H. NGP356810H. NGP356811H NGP356876H NGP356894H NGP356914H NGP356979H NGP356985H NGP356997H NGP357009H NGP357023H NGP357043H NGP357061 NGP357091 NGP357252H NGP357292H NG P3 5731 SH NGP357351 NGP357381 NGP357426H NGP357455H NGP357469H NGP357475H NGP357484H . NGP356812H . NGP356851 NGP356864H . NGP356877H NGP356896H NGP356915H . NGP356967H . NGP356974H . NGP356989H . NGP356999H . NGP357010H NGP357024H . NIGP357044H NGP357080H .NGP356813H, . NGP356852H. NGP356865H, .NGP356881H. . NGP356902H. .NGP356916H. NGP356968H, .NGP356975H. .NGP356981H. . . NGP357002H. . NGP357011H. . NGP357039H, . NGP357045H, . NGP357086H. NGP355814H, NGP356855H. NGP3 56 856H, NGP356816H thru NGP356856H. NGP356860H. NGP356359H, NGP356889H. NGP356892H. NGP356893H, NGP356911H. NGP355912H, NGP356913H, NGP356919H thru NGP356946H. NGP355949H thru NGP356959H. NGP356970H, NGP356972H. NGP356976H. NGP355978H. NGP355982H, NGP355983H. NGP356984H. NGP356993H. NGP356994H, NGP355996H, NGP357004H, NGP357005H. NGP357012H. NGP357015H. NGP357016H. NGP357040H. NGP357041H. NGP357042H. NGP357056H. NGP357059H. NGP357088H, NGP357089H. .NGP357092H thru NGP357106H. thru NGP357124H, NGP357126H. NGP357128H thru NGP357191H. NGP357235H, NGP357237H thru NGP357254H thru NGP357286H. NGP357288H. NGP357291H. . NGP357294H, .NGP357316H, . NGP357355H, NGP357385H, .NGP357455H. . NGP357470H. . NGP357478H. . NGP357486H. NGP357295H. NGP357323H NGP357357H. NGP357385H. NGP357438H NGP35746 3H. NGP357471H, NGP357479H NGP357304H. NGP357313H. NGP357314H, . NGP357339H, NGP357347H. NGP357358H, NGP357364H, NGP357379H. NGP357388H thru NGP357407H. thru .NGP357441H. NGP357453H. NGP357466H. NGP357467H, NGP357468H. NGP357472H, NGP357473H. NGP357474H. . NGP357480H, NGP357482H, NGP357483H. NGP357488H, NGP357489H. NGP357491H. 3/21/2013 Medical Radiation Emitting Device Recalls Page 4 of 1 NGP357492H, NGP357494H, NGP357497H. NGP357499H, NGP357500H. NGP357501H. NGP357502H, NGP357503H, NGP357505H, NGP357506H, NGP357507H. NGP357512H. NGP357513H. NGP357514H. NGP357520H. NGP357521H. NGP357522H. NGP357523H. NGP357527H, NGP357528H, NGP357564H, NGP357565H. NGP357566H. NGP357568H lhru NGP357584H. NGP357585H thru NGP357607H, NGP357609H. NGP357610H, thru NGP357626H. NGP357535H thru NGP357705H, thru NGP357717H. NGP357719H, NGP357721H thru NGP357737H, NGP357740H, NGP357741H. NGP357743H. NGP357744H, NGP357745H, NGP357747H thru NGP357760H, NGP357762H, NGP357763H, NGP357764H, NGP357765H, NGP357766H, NGP357767H, NGP357758H, NGP357770H, NGP357771H, NGP357772H. NGP357773H, NGP357775H thru NGP357791H. NGP357793H, NGP357794H NGP357BD1 NGP357854H, NGP357855H NG P3 57884H NGP357885H . NGP357795H, NGP357802H, NGP357808H, NGP357B10H, NGP357322H. NGP357834H, NGP357844H, NGP357845H, NGP357812H, NGP357827H, NGP357837H. NGP357846H. NGP357857H, NGP357864H, NGP357865H, NGP357875H, NGP357877H. . NGP357939H, NGP357941H, NGP357946H, NGP357948H, NGP357955H. NGP357964H. NGP357967H. NGP357975H, NGP357976H, NGP357981H. NGP357982H. NGP357988H, NGP357989H, NGP357996H thru NGP358014H. NGP358016H, NGP358021H. NGP358024H. NGP357879H, NGP357899H. NGP357942H. NGP357949H, NGP357958H. NGP357968H. NGP357977H, NGP357990H, NGP357797H, NGP357803H NGP357813H. NGP357840H. NGP357847H. NGP357889H, NGP357950H, NGP357960H. NGP357969H, NGP357978H, NGP357984H. NGP 357991 H, NGP357798H, . NGP357804H, NGP357816H, NGP357830H. NGP3 57841 . NGP357849H. NGP357860H, NGP357871 H, NGP3578 82H, NGP357944H, NGP357952H, NGP357951H. NGP357972H. NGP357979H, NGP357985H. NGP357992H, NGP357799H. NGP357806H. NGP357818H, NGP357833H. NGP357843H, NGP357853H. NGP357863H. NGP357873H. NGP357883H. NGP357896H. thru NGP357928H thru NGP35794SH, NGP357953H, NGP357963H, NGP357973H. NGP357980H, NGP357986H. NGP357994H, NGP358026H. NGP358028H. NGP358029H. NGP358033H. NGP353034H. NGP358035H. NGP358037H. NGP358039H thru NGP358053H, NGP358055H thru NGP358065H. NGP358070H thru NGP358033H. thru NGP358097H, NGP358098H. NGP358099H, NGP358105H, NGP358108H, NGP358122H, NGP358123H. NGP358135H.NGP358144H. NGP358159H, NGP358161H. NGP358174H, . NGP358192H. NGP358209H, NGP358216H, NGP353219H, NGP358225H. NGP358236H. NGP358250H. NGP358187H, NGP358191 56H NGP358269H NGP 35 82 97H NGP358347H NGP358365H NGP358391 NGP358415H NGP358436H NGP358445H NGP358454H NGP358465H NGP358473H NGP358487H NG P3584 95H NGP358513H NG P3585 26H NGP358547H NGP358569H NGP358583H NGP358592H .NGP358257H. NGP35827DH, NGP358279H. NGP358298H. . NGP358321H. .NGP358348H, . NGP358392H. NGP358438H, . NGP358446H, NGP358458H. . NGP358475H, . NGP358488H, . NGP358496H. . NGP358531H, . NGP358552H. NGP358570H, . NGP358598H. NGP358599H NGP358619H NGP358646H, NGP358648H NGP358653H, NGP358655H NG P3 5868 SH. NGP358586H NGP358101H, NGP358112H. NGP358124H. NGP358147H, NGP358163H. NGP358178H, NGP35321 1 H, NGP358231 H, NGP358238H, NGP358260H. NGP358271H. NGP358285H. NGP358301H, NGP358325H. NGP358350H. NGP358375H, NGP358399H. NGP358417H, NGP358440H, NGP35844TH. NGP358468H. NGP358476H. NGP358490H, NGP358499H. NGP358516H. NGP358532H, NGP358557H, NGP358585H, NGP358594H. .NGP358600H. NGP358605H, NGP358605H, NGP358511H, NGP358607H, NGP358514H. . NGPESBEZUH. NGP358629H, NGP358630H. NGP358639H, NGP358640H. NGP358633H. NGP358541 H, .NGP358649H. NGP358662H. NGP358664H, NGP358670H, NGP358671H. NGP358665H. NGP358672H. . NGP358689H, NGP358696H, NGP358697H. NGP3S 85991-1. NGP358102H. 13H, NGP358130H NGP358149H, NGP358164H. NGP358180H. NGP358212H H. NGP358232H. NGP358240H. NGP358253H, NGP358255H. NGP353272H. NGP358289H. NGP358329H NGP358353H NGP358381 H, NGP358408H. NGP358421 H, NGP358450H. .NGP358464H. .NGP358471H. .NGP358485H. NGP358448H NGP358460H NGP358469H NGP358480H NGP358504H, NGP358520H. NGP353533H, NGP358558H NGP358573H. NGP358586H, NGP358595H. H. NGP358608H, NGP358515H, NGP358621 H. NGP358635H NGP358642H, NGP358650H. NGP358659H, NGP358667H NGP358700H, NGP358103H. NGP358115H, . NGP358131H, NGP358152H, NGP358165H, NGP358184H, . NGP358200H, .NGP358213H, NGPS 58222 H. NGP358234H, NGP358245H, NGP358254H. NGP358266H, NGP358275H. NGP358309H, NGP358333H, NGP358358H. NGP358386H, NGP35841 1 H. NGP358427H. NGP358443H, NGP358492H, NGP358505H, NGP358524H. NGP358543H. . NGP358563H, NGP358537H, NGP358595H, NGP358602H, NGP358609H, NGP358622H, NGP358543H, NGP358560H, NGP358668 H, .NGP358680H, NGP358692H, NGP358702H, NGP353104H. NGP3531 21 H, NGP358134H. NGP358157H, NGP358168H. NGP358202H, NGP358215H. NGP358223H. NGP353235H. NGP358247H, NGP358255H, NGP358268H, NGP358276H. NGP358294H. NGP358338H, NGP358360H. NGP358387H, NGP358412H, NGP358430H. NGP358444H, NGP358453H, NGP358465H, NGP358472H, NGP358486H, NGP358493H. NGP358507H. NGP358525H, NGP358544H. NGP358568H. NGP358580H, NGP358591 H. NGP353597H. NGP358604H, NGP358610H, NGP358628H, NGP358637H, NGP358645H, NGP358652H, NGP358651 H, NGP358669H. NGP358581 H, NGP358593H. NGP358703H. 3/21/2013 Medical Radiation Emitting Device NGP358705H NGP358716H NGP358725H NG P3587 34H NGP358741 NGP358770H NGP3 587 77H NGP358795H NGP358804H NGP358811H NGP3 58821 NGP358829H NGP358838H NGP358847H NGP358872H NGP358886H NGP358907H NGP358922H NGP358937H NGP358943H NGP358950H NG P359001 NGP359048H NGP359055H NGP359062H NGP359069H NGP359077H NGP359088H NGP359098H NGP359106H NGP359112H NGP359121H Recalls . . NGP358735H. . NGP358742H, . NGP358772H. NGP358778H, NGP358796H, . NGP358805H. .NGP358823H. .NGP358831H. . NGP358839H. .NGP358874H. NGP358890H. . NGP358908H. .NGP358925H. 1 NGP358938H. NGP359002H, NGP359049H. . NGP359056H, NGP359064H, .NGP359071H. NGP359080H. . NGP359089H. NGP359099H, .NGP359107H. NGP359229H. NGP358707H, NGP358718H. NGP358729H, NGP358736H. NGP35874 3H NGP358773H NGP3 5877 SH NGP358815H NGP358825H. NGP358832H, NGP358840H, NGP358859H. NGP358876H. NGP358892H NGP353910H, NGP358926H, NGP358939H NGP358946H NGP358952H NGP359003H NGP3 5905711 NGP359065H NGP359072H NGP359081 NGP359090H NGP359100H NGP359114H NGP359123H NGP359230H NGP358826H. NGP358833H, NGP358841H, NGP353861H, NGP358878H. . NGP358895H. NGP358916H. NGP358927H. NGP358940H. . NGP358947H. NGP358953H, .NGP359051H, . . NGP359066H, NGP359073H, . NGP359083H, .NGP359091H. NGP359224H. NGP359231H. NGP358710H. NGP358711H. NGP358721H. NGP358731H. NGP358732H. NGP358737H, NGP358739H. NGP358745H. NGP358775H. NGP358781H thru NGP358792H. NGP358794H. NGP358801H. NGP358809H. NGP358817H. NGP358827H, NGP358834H, NGP358842H. NGP358863H, NGP358880H, NGP358898H, NGP358917H, NGP358935H. NGP358941H, NGP358948H, NGP358955chru NGP358972H, NGP358974H thru NGP358994H, NGP358996H. NGP358997H. NGP358999H, . NGP359004H ihru NGP359044H, NGP359047H, NGP359052H, NGP359060H. NGP359067H. NGP359074H. NGP359095H, NGP359104H, NGP359110H. NGP359119H. NGP359225H. NGP359232H. NG P3 5871 4H, NGP358722H. NGP358733H, NGP35874BH thru NGP358776H. NGP358802H. NGP358810H, NGP358820H. NGP358837H. NGP358844H, NGP 358871 H. NGP358885H. NGP358905H. NGP358918H. NGP358936H. NGP358942H. NGP358949H. NGP359053H. NGP359061H. NGP359068H, . NGP359087H. NGP359097H, NGP359105H. NGP3591 11H. NGP359120H. NGP359227H. NGP359233H. Page 5 ofll NGP359234H. NGP359235H. NGP359237H thru NGP359251H. NGP359253H thru NGP359252H. NGP359264H. NGP359266H, NGP359267H. NGP359258H. NGP359270H. NGP359271H. NGP359272H. NGP359274H. NGP359275H, NGP359280H, NGP359281H. NGP359290H. NGP359291H, NGP359300H. NGP359302H. NGP359303H. NGP359305H. NGP359310H, NGP359314H, NGP359320H. NGP359323H. NGV000236R thru NGV000334R. NGV000557N thru NGV028001N. NGVSODOOZH thru NGV445681H. NGV445683H. NGV445685H thru NGV445700H. NGV445702H, NGV445704H. NGV445705H. NGV4457U7H tru NGV445727H, NGV445730H, NGV445731H, NGV445732H. NGV445734H thru NGV445776H. NGV445778H thru NGV445792H, NGV445795H thru NGV445834H, NGV445836H thru NGV445939H. NGV445941H thru NGV445962H thru NGV445975H. NGV445977H. NGV44597BH. NGV445979H. NGV44598OH. NGV445981H. NGV445982H, NGV445983H. NGV445984H. NGV445985H. NGV445988H. NGV445989H. NGV445990H. NGV445991H, NGV445992H. NGV445994H. NGV445996H thru NGV446011H. NGV446012H. NGV446014H thru NGV446052H. NGV446054H. NGV446055H. NGV446055H. NGV446057H, NGV446058H. NGV446059H. NGV446060H. NGV446061H. NGV446063H thru NGV446135H. NGV446137H, NGV446138H, NGV446139H. NGV446140H, NGV446141H. NGV446142H. NGV446143H. NGV44B144H. NGV446146H thru NGV446175H, NGV446177H. NGV446178H, NGV446179H, NGV446180H, NGV446182H thru NGV446362H. NGV446354H thru NGV445375H, NGV446377H thru NGV446398H, NGV445407H. NGV446408H thru NGV446437H, NGV445439H thru NGV446502H, NGV446504H thru NGV446718H, NGV446720H, NGV446721H, NGV446722H. NGV446724H, NGV446725H, NGV446726H. NGV446728H thru NGV446751H thru NGV446768H. NGV445770H thru NGV446805H, NGV446806H, NGV446807H, NGV446808H. NGV446809H, NGV446810H. NGV446811H, NGV446812H, NGV446813H. NGV446814H, NGV446817H, NGV44681BH. NGV446319H. NGV446820H. NGV44EB22H. NGV446823H. NGV446824H, NGV446825H. NGV446826H, NGV446827H. NGV446328H, NGV446829H, NGV446831 thru NGV446918H. NGV446920H thru NGV446955H. NGV445957H thru NGV447159H. NGV447161H thru NGV447212H, NGV447214H thru NGV447227H. NGV447229H. NGV447231H thru NGV447251H thru NGV447274H. NGV447276H. NGV447277H, NGV447278H, NGV447279H. NGV447280H. NGV447281H. NGV447282H. NGV447283H, NGV447284H, NGV447285H. NGV447286H. NGV447288H thru NGV447298H. NGV447300H, NGV447301H, NGV447302H. NGV447304H, NGV447305H. NGV447305H, NGV447307H, NGV447308H. NGV447310H. NGV447311H. NGV447313H, NGV447314H. NGV447315H. NGV447316H, NGV447319H. NGV447321H thru NGV447337H, NGV447339H. NGV447341H. NGV447343H. NGV447344H, NGV447346H, NGV447352H NGV447358H NGV447356H NGV447374H NGV447381H NGV447389H NGV447395H NGV447402H . NGV447353H. . NGV447359H, . NGV447367H. NGV447375H. . NGV447382H. . NGV447390H, . NGV447396H, NGV447403H. NGV447347H. NGV447354H, NGV447350H. NGV447358H NGV447377H. NGV447383H. NGV447391 NGV447397H, NGV447404H. NGV447348H, NGV447355H. NGV447351H. . NGV447369H. NGV447378H NGV447384H, NGV447392H, NGV447398H NGV447350H. NGV447364H. NGV447371H, . NGV447379H. NGV447393H. NGV447399H, NGV447407H thru NGV447423H. NGV447425H thru NGV447351H, NGV447357H, NGV447365H. NGV447372H. NGV447380H. NGV447387H. NGV447394H, NGV447401H, 3/21/2013 Medical Radiation Emitting Device Recalls NGV447530H, NGV447532H NGV447547H. NGV447549H thru NGV447923H. NGV447925H lhru NGV447967H. NGV447969H thru NGV448122H. NGV448124H thru NGV448152H. NGV448154H lhru NGV448211H. NGV448213H thru NGV448229H. NGV448231 thru NGV448294H, NGV448296H thru NGV448311H. NGV448313H thru NGV448323H, NGV448325H thru NGV448391H. NGV448393H thru NGV448456H. NGV448458H. NGV448461H thru NGV448470H, NGV448472H. NGV448473H. NGV448474H. NGV448477H, NGV448478H. NGV448479H. NGV448481H. NGV44B4BTH, NGV448489H, NGV448490H, NGV448491H. NGV443494H, NGV448496H, NGV448505H, NGV448506H. NGV448512H. NGV448513H. NGV448521H. NGV448522H. NGV448529H, NGV448530H, NGV448593H. NGV443599H. NGV448635H. NGV448636H, NGV448650H, NGV448653H, NGV448661 H, NGV448562H. NGV448668H, NGV448670H. NGV448677H. NGV448681H. NGV448688H. NGV448589H. NGV448696H. NGV448703H. NGV448704H. NGV448791H. NGV44B792H. NGV448797H. NGV448798H. NGV448805H, NGV448806H. NGV448812H, NGV448813H. NGV448822H. NGV448824H. NGV448834H. NGV448836H. NGV448844H, NGV448846H, NGV448852H, NGV448855H. NGV448865H. NGV448856H, NGV448875H, NGV448876H. NGV449009H. NGV449010H. NGV449126H. NGV449128H, NGV449342H. NGV449344H, NGV449351H. NGV449352H. NGV449357H. NGV449358H, NGV449366H. NGV449367H, NGV449376H, NGV449377H. NGV449384H, NGV449385H, NGV449393H. NGV449394H. NGV449403H, NGV449404H. NGV449443H. NGV449447H. NGV44951 1 H, NGV449512H. NGV449518H, NGV449519H. NGV449527H, NGV449536H, NGV449537H. NGV449545H, NGV449546H, NGV449555H, NGV449556H. NGV449561H, NGV449562H, NGV449568H, NGV449569H, NGV449577H, NGV449578H, NGV449583H, NGV449584H, NGV449590H, NGV449591H. NGV449600H, NGV449601H. NGV449609H, NGV449610H. NGV44961BH, NGV449619H. NGV449625H, NGV449625H. NGV449655H, NGV449658H, NGV449662H. NGV449663H. NGV449674H. NGV449680H. NGV449691H. NGV449693H. NGV449710H. NGV449713H. NGV449727H. NGV449734H. NGV44QY45H. NGV449750H. NGV449763H. NGV449755H. NGV449784H. NGV449790H. NGV449809H, NGV449814H. NGV449828H. NGV449831 H. NGV449837H. NGV449839H, NGV449856H, NGV449860H, NGV449877H, NGV449885H. NGV448497H NGV448507H NGV448515H NGV448523H NGV448637H NGV448656H NGV448663H NGV44 8671 NGV448682H NGV448690H NGV448699H NGV44B7USH NGV448793H, NGV448300H, NGV448808H. NGV448814H. NGV443828H. NGV448837H. NGV448847H. NGV448859H. NGV448857H. NGV44 887 7H. NGV449345H, NGV449353H. NGV449359H, NGV449368H, NGV449330H. NGV449385H, NGV449395H, NGV4 4940 SH, NGV449454H. NGV449513H. NGV449521H. NGV449529H. NGV449538H. NGV449547H. NGV449557H. NGV449563H. NGV44 9571 H. NGV449579H. NGV449535H. NGV449594H. NGV449605H. NGV44 951 1H. NGV449620H. NGV449658H. NGV44 9664 H. NGV44968 1 H. NGV449597H NGV449716H, NGV449751 NGV449793H. NGV449817H. NGV4493 33H. NGV449844H. NGV449863H. NGV449888H NGV448498H, . NGV448508H. NGV44851TH, . NGV443524H, NGV448531H. NGV448537H thru NGV448595H. NGV448597H. NGV448601H thru NGV448533H, NGV448634H. NGV44BB3BH, NGV448657H, NGV448665H, NGV44BS74H, . NGV448683H, NGV448664H . NGV448672H . NGV448692H. . NGV448700H, . NGV448706H. NGV448794H, NGV448802H. NGV448809H. NGV448817H. NGV448829H. NGV448839H. NGV448349H, NGV448851H. NGV448870H. NGV449348H NGV449354H NGV449360H, NGV449369H, NGV449381H. NGV449387H NGV449395H NGV449405H NGV449491 NGV449514H NGV449522H NGV449532H. NGV449539H. NGV449549H. NGV449558H NGV449564H NGV449572H. NGV449580H NGV449586H NGV449596H NGV449606H NGV449612H. NGV449621H, NGV449659H NGV449665H NGV449682H . NGV449698H NGV449718H. NGV449737H. NGV449754H NGV449774H NGV449794H NGV449818H. NGV449834H. NGV449848H NGV449864H. . NGV449892H. NGV448475H. NGV448484H, NGV44B492H, NGV448501 H. NGV448510H. NGV44851BH, NGV44852TH. NGV448541H, NGV448659H. NGV448684H. NGV448693H. NGV448701H, NGV448707H. NGV448795H, NGV448803H, NGV44881UH, NGV448819H, NGV448832H, NGV448841 . NGV448850H. NGV448862H, NGV448872H. NGV449362H. NGV449371H. NGV449382H. NGV4493BBH, NGV449398H. NGV449409H, . NGV449505H, . NGV449524H, NGV449533H, NGV44954UH, NGV449551 . . NGV449559H, . NGV449565H. NGV449573H, . NGV449581H, . NGV449587H. . NGV449598H. . NGV449607H, NGV449615H, NGV449623H, NGV449719H. NGV449738H. . NGV449759H, NGV449777H. NGV449796H. NGV449823H NGV449835H, NGV449873H NGV449896H. gov/scripts/cdrh/c 1 02261 NGV448476H. NGV448485H, NGV448493H, NGV448502H. NGV44851 1 H. NGV448520H. NGV448528H, NGV448647H, NGV448660H. NGV443667H, NGV448675H, NGV448687H, NGV448594H. NGV448702H. NGV448708H. NGV448709H. NGV448711H thru NGV448730H, NGV448732H lhru NGV448788H. NGV448790H, NGV448796H. NGV448804H, NGV448811H. NGV448820H. NGV448833H. NGV448842H. NGV448851H. NGV448863H. NGV448874H. NGV448879H thru NGV448892H, NGV448894H. NGV448896H thru NGV448932H. NGV448934H. NGV448936H. NGV446937H. NGV448933H. NGV448939H, NGV448940H, NGV448941H. NGV448942H, NGV448943H. NGV448944H, NGV448946H, NGV448947H. NGV44BQ4BH. NGV448949H. NGV448950H. NGV448951H, NGV448952H. NGV448953H, NGV448954H. NGV448956H. NGV448957H. NGV448958H. NGV448960H thru NGV449003H. NGV449006H. NGV449008H. NGV449011H. NGV449013H thru NGV449038H. NGV449040H thru NGV449130H thru NGV449160H. NGV449162H. NGV449163H thru NGV449349H. . NGV449355H. NGV449350H. NGV449356H. NGV449363H, NGV449373H, NGV449383H, NGV449392H, NGV449400H, NGV449422H. NGV449510H. NGV449517H, NGV449526H. NGV449535H. NGV449543H. NGV449553H. NGV449560H, NGV449566H, NGV449576H, NGV449582H, NGV449589H. NGV449599H. NGV449608H. NGV449616H. NGV449624H. NGV449628H thru NGV449641H. NGV449645H. NGV449648H. . NGV449660H. . NGV449669H. NGV449687H. . NGV449703H. NGV44 9661 H. NGV449571H. NGV449638H. NGV449704H, NGV449723H. NGV449739H. NGV449760H. NGV449782H. NGV449807H, . NGV449825H, NGV449836H, NGV44 98 52H, . NGV449876H. NGV449904H. Page 6 of 11 3/21/2013 NGV449905H. NGV44993GH. NGV449938H, NGV449944H, NGV449952H. NGV449958H. NGV449970H, NGV449976H, NGV449983H. NGV449992H. NGV449999H. NGV450037H. NGV450044H. NGV450051H. NGV450057H, NGV450064H, NGV450072H. NGV450030H. NGV450086H, NGV450206H. NGV450214H. NGV450223H, NGV450253H. NGV450266H, NGV450273H. NGV450282H, NGV450308H, NGV450315H, NGV450322H, NGV450323H, NGV450337H. NGV450345H, NGV450356H, NGV450365H. NGV450373H. NGV450384H, NGV450395H, NGV450405H. NGV450413H. NGV450421 H. NGV450428H. NGV450434H. NGV450448H. NGV450456H. NGV450469H. NGV450485H. NGV450493H. NGV450503H. NGV450520H, NGV450528H, NGV450547H, NGV450555H. NGV450566H, NGV450574H. NGV450585H, NGV450594H, NGV450603H, NGV450612H. NGV450621H. NGV450634H. NGV450542H. NGV450675H. NGV450683H. NGV450702H. NGV450709H. NGV450715H, NGV450723H, NGV450729H, NGV450738H. NGV450747H, NGV450755H. NGV450763H. NGV450771H. NGV450779H, Medical Radiation Emitting Device Recalls NGV449907H. NGV449932H. NGV449939H. NGV449945H, NGV449953H. NGV449959H, NGV449971H, NGV449977H, NGV449984H, NGV449993H. NGV450000H, NGV450038H, NGV450045H, NGV450052H. NGV450058H, NGV450066H. NGV450074H. NGV450081 H. NGV450088H thru NGV45011OH. NGV450112H. NGV450113H. NGV450117H. NGV450127H thru NGV450204H. NGV450212H. NGV450213H. NGV450220H. NGV450221H. NGV450229H, NGV450230H, NGV450242H. NGV450243H. NGV450251H, NGV450252H, NGV450262H, NGV450255H. NGV45027UH, NGV450272H. NGV450280H, NGV450281 H. NGV450285H thru NGV450302H. NGV450304H. NGV450314H, . NGV450320H. NGV450321H. . NGV450326H, NGV450327H. . NGV450332H. NGV450335H. . NGV450342H. NGV450343H. . NGV450354H. NGV450355H. . NGV450360H. NGV450363H. . NGV450371H. NGV450372H. NGV450379H. NGV450380H. . NGV450391H, NGV450394H. . NGV450402H. . NGV450409H. NGV450419H. NGV450420H. NGV450426H, NGV450427H. NGV450432H. NGV450433H. NGV450442H. NGV450446H. . NGV450454H. NGV450455H. NGV450454H. NGV450455H. . NGV450479H. . NGV450491H. . NGV450498H, NGV450500H, . NGV450519H, . NGV450524H. NGV450525H. NGV450536H, NGV450538H. . NGV450553H. NGV450554H, . NGV450563H. NGV450565H. . NGV450572H, NGV450573H, . NGV450583H, NGV450584H. NGV450589H. NGV450592H. . NGV450602H. . NGV450608H. NGV450609H. . NGV450619H. . NGV450533H, . NGV450540H. NGV450541H. NGV450544H, NGV450646H thru NGV450664H. NGV450666H thru NGV450682H, NGV450689H. NGV450692H. . NGV450700H, NGV450701H. . NGV450706H, NGV450708H. . NGV450713H, NGV450714H. . NGV450720H, NGV450721H. . NGV450727H. NGV450728H. . NGV450735H, NGV450736H. . NGV450744H. NGV450745H, NGV450753H. NGV450754H. . NGV450761H. NGV450768H. NGV450770H, . NGV450775H, NGV450778H. . NGV450785H. NGV450207H. NGV450217H. NGV450224H. NGV450235H. NGV45024BH, NGV450256H. NGV450267H. NGV450275H. NGV450284H. NGV450309H, NGV450323H, NGV450329H. NGV450338H. NGV450347H. NGV450357H, NGV450356H, NGV450374H, NGV450385H, NGV450396H, NGV450406H, NGV450415H, NGV450422H. NGV450429H. NGV450435H, NGV450450H. NGV450457H. NGV450472H, NGV450488H. NGV450494H. NGV45051 ?1 H. NGV450521H. NGV450533H, NGV450548H, NGV450555H, NGV450557H. NGV450575H, NGV450586H, NGV450595H. NGV450604H, NGV450615H. NGV450622H, NGV450637H. NGV450643H. NGV450677H, NGV450584H, NGV450594H. NGV450703H, NGV450710H. NGV450716H, NGV450724H, NGV450730H. NGV450739H. NGV450749H1 NGV450756H. NGV450764H, NGV450772H. NGV450780H. NGV449908H, NGV449910H thru NGV449929H, NGV449935H. NGV449935H, . NGV449942H. NGV449943H. NGV449949H, NGV449950H, . NGV449956H. NGV449957H. . NGV449966H. NGV449968H. . NGV449974H, NGV449975H, . NGV449981H. NGV449982H. . NGV449988H. NGV449991H. . NGV449997H. NGV449998H. NGV450003H thru NGV450034H. NGV450035H, NGV450042H. NGV450043H. . NGV450049H, NGV450058H. . NGV450063H. . NGV450069H. NGV450071H. NGV449933H. NGV449940H. NGV449946H. NGV449954H. NGV449963H. NGV449972H, NGV449978H. NGV449985H, NGV449994H. NGV450001H. NGV450039H. NGV450046H. NGV450067H, NGV449934H NGV449941 NGV449947H NGV449955H NGV449955H NGV449973H NGV449980H NGV449987H NGV449995H NGV450041 NGV450047H NGV450054H NGV450050H NGV450068H NGV450076H. NGV450077H NGV450082H, NGV450083H NGV450079H. NGV450084H, NGV450035H, NGV450125H, NGV450208H, NGV45021 1 H. NGV450218H. NGV450219H. NGV450225H, NGV450227H, NGV450236H, NGV450237H. NGV450249H, NGV450250H, NGV450259H, NGV450260H. NGV450268H. NGV450269H. NGV450278H. NGV450310H, NGV450311H NGV450317H, NGV450319H NGV450324H, NGV450325H NGV450330H. NGV450331 NGV450339H, NGV450341 NGV450350H. NGV450352H NGV450358H. NGV450359H NGV450367H, NGV450358H NGV450376H. NGV450377H NGV450390H NGV450398H. NGV450399H NGV450407H, NGV450408H NGV450417H, NGV450418H NGV450424H NGV450430H. NGV450431 NGV450436H. NGV450438H NGV450451H. NGV450452H NGV450461 NGV450474H. NGV450478H NGV450489H. NGV450490H NGV450495H. NGV450497H NGV450513H. NGV450516H NGV450523H NGV450534H. NGV450535H NGV450549H. NGV450551 NGV450557H. NGV450558H NGV450568H. NGV45057OH NGV450580H. NGV450582H NGV450587H, NGV450588H NGV450597H, NGV450600H NGV450605H. NGV450606H NGV450616H, NGV450617H NGV450623H. NGV450625H NGV450638H, NGV450639H NGV450678H. NGV450680H NGV450686H. NGV450688H NGV450696H, NGV450697H NGV4SD705H NGV4SD717H. NGV450713H NGV450725H. NGV450726H NGV450732H, NGV450733H NGV450740H, NGV450742H NGV450750H. NGV450751 NGV450758H, NGV450759H NGV450765H. NGV450767H NGV450774H NGV450781 H, NGV450782H Page 7 ofll 3/21/2013 Medical Radiation Emitting Device Recalls NGV450796H, NGV450805H. NGV450814H, NGV450819H. NGV450820H. NGV450826H, NGV450827H. NGV450833H, NGV450834H. NGV450839H. NGV450840H. NGV450859H, NGV450861H. NGV450870H, NGV450871H. NGV450885H. NGV450904H. NGV450905H. NGV450921H, NGV450923H, NGV450938H, NGV450939H, NGV450952H, NGV450954H. NGV450964H, NGV450965H, NGV450798H NGV450807H NGV450815H NGV4 50821 NGV450828H NGV450835H NGV4 50841 NGV450853H NGV450372H NGV450891 NGV450906H NGV450926H NGV450942H NGV450959H NGV450956H NGV450799H, . NGV450809H. NGV450822H. NGV450829H. . NGV450836H. NGV450842H. . NGV450864H. .NGV450874H. . NGV450895H. . NGV450907H. . NGV450928H, . NGV450947H. . NGV450960H. NGV450967H. NGV450800H. NGV450811H, NGV450817H. NGV450824H. NGV450830H. NGV450837H, NGV450843H. NGV450866H, NGV450883H. NGV450899H, NGV450914H. NGV450930H, NGV450950H. NGV450961 H. NGV450968H, NGV450801H. NGV450812H. NGV450818H. NGV450825H. NGV450832H. NGV45083BH, NGV450845H thru NGV450900H. NGV450915H. NGV450951H. NGV450953H. NGV450970H, Page 8 ofll NGV450976H. NGV450979H, NGV450981H thru NGV451007H. NGV451011H, NGV451013H, NGV451014H. NGV451D16H. NGV451017H. NGV451019H. NGV451020H. NGV451021H, NGV451024H, NGV451027H, NGV451031H. NGV451U34H. NGV451035H. NGV451037H, NGV451038H. NGV451U39H. NGV451G40H. NGV451041H. NGV451042H. NGV451043H, NGV451044H, NGV451046H. NGV451047H. NGV451051H. NGV451052H. NGV451055H. NGV451056H, NGV451058H. NGV451060H. NGV451062H, NGV451065H. NGV451066H, NGV451073H, NGV451075H. NGV451076H. NGV451077H. NGV451078H, NGV451080H. NGV451082H, NGV451083H, NGV451084H. NGV451085H, NGV451OB7H, NGV451089H, NGV451090H. NGV451092H. NGV451093H, NGV451094H, NGV451097H. NGV451099H, NGV451102H. NGV451103H, NGV451104H, NGV451106H, NGV451107H, NGV451103H, NGV451111H, NGV451112H, NGV451114H, NGV451115H, NGV45111EH, NGV451119H. NGV451120H, NGV451121H, NGV451122H, NGV451123H, NGV451125H. NGV451127H. NGV451130H, NGV451132H. NGV451133H, NGV451135H. NGV451139H, NGV451142H, NGV451143H, NGV451145H, NGV45114BH, NGV451149H, NGV451150H, NGV451151H. NGV451152H, NGV451153H. NGV451154H, NGV451155H. NGV451158H, NGV451161H. NGV451163H. NGV451164H. NGV451165H, NGV4511B3H, NGV451185H thru NGV451212H. NGV451214H. NGV451215H, NGV451216H, NGV451222H, NGV451224H, NGV451229H. NGV451230H, NGV451250H, NGV451252H, NGV451257H, NGV451259H, NGV451265H. NGV451266H. NGV451271H, NGV451272H, NGV451281H, NGV451282H. NGV451287H. NGV451290H, NGV451297H. NGV451298H. NGV451305H, NGV451306H. NGV451311H. NGV451312H, NGV451318H. NGV451319H, NGV451326H. NGV451327H. NGV451335H, NGV451337H, NGV451350H NGV451358H. NGV451363H. NGV451371H. NGV451372H. NGV451377H. NGV451378H. NGV451387H. NGV451389H, NGV451399H. NGV451401H, NGV451418H. NGV451419H, NGV451424H. NGV451425H. NGV451439H. NGV451446H. NGV451453H, NGV451459H. NGV451450H. NGV451458H. NGV451469H. NGV451475H. NGV451476H. NGV451483H, NGV451487H. NGV451492H. NGV451493H. NGV451505H. NGV451506H NGV451511H. NGV451512H NGV451711H, NGV451713H. NGV451728H, NGV451741H. NGV451768H, NGV451777H, NGV451799H, NGV451801H. NGV451811H. NGV451817H, NGV451827H. NGV451829H, NGV451841H. NGV451848H. NGV451856H. NGV451857H. NGV451864H. NGV451868H, NGV451876H. NGV451878H. NGV451218H. NGV451225H. NGV451231H. NGV451253H. . NGV451268H. NGV451273H. NGV451283H. NGV451292H. NGV451299H. NGV451307H. NGV451320H. NGV451328H. NGV451339H, .NGV451351H. NGV451364H, NGV451267H NGV451313H NGV451373H NGV451380H NGV451447H NGV451714H. NGV451742H. NGV451781H NGV451822H NGV451833H NGV451869H NGV451219H. NGV451225H, NGV451232H. MGV451254H1 NGV451274H. NGV451284H. NGV451293H. NGV451300H, NGV451308H, NGV451321H. NGV451329H, NGV451340H. NGV451352H. NGV451365H. NGV451391H, NGV451405H, NGV451420H, NGV451426H, NGV451440H. NGV451455H, NGV451461H. NGV451470H. NGV451477H, NGV451488H, NGV451496H, NGV451507H, NGV451392H NGV451407H NGV451421H, NGV451430H, NGV451441H, NGV451456H NGV451462H, NGV451472H NGV451480H. NGV451489H. NGV451498H. NGV451719H NGV451752H. NGV451786H, NGV451804H. NGV451806H NGV451844H NGV451851H, NGV451859H, .NGV451870H, NGV451879H. NGV451880H, NGV451220H, NGV451221H, NGV451227H. NGV451228H. NGV451234H thru NGV451248H. NGV451255H. NGV451256H. NGV451473H . NGV451808H .NGV451824H. . NGV451836H. NGV451843H, NGV451850H. NGV451858H. NGV4S1262H NGV451269H NGV451278H. NGV451285H. NGV451295H. NGV451303H, NGV451309H. NGV451315H NGV451322H. NGV451331H. NGV451 341 H. NGV451354H. NGV451366H. NGV451375H. NGV451385H. NGV451413H NGV451422H. NGV451431H, NGV451442H, NGV451450H. NGV451463H. NGV451481 NGV451490H NGV451503H NGV451509H. NGV451762H. NGV451787H. NGV451825H, NGV451837H, .NGV451B45H. NGV451852H NGV451861 NGV451873H. NGV451881 H. .NGV451264H. . NGV451270H. NGV451280H. NGV451296H. NGV451304H. NGV451310H. NGV451324H. NGV451332H. NGV451343H, NGV451355H. NGV451369H. NGV451376H. NGV451336H. NGV451397H, NGV451436H. NGV451444H. NGV451451H. NGV451458H. NGV451465H. .NGV451474H. .NGV451482H. .NGV451491H. .NGV451504H NGV451514H. NGV451516H thru NGV451603H. NGV451605H lhru NGV451640H. NGV451642H thru NGV451707H, NGV451709H, NGV451710H. NGV451725H, NGV451765H. NGV451795H. .NGV451809H. NGV451826H. NGV451838H. NGV451853H. .NGV451862H. NGV451874H. NGV451882H, 3/21/2013 Medical Radiation Emitting Device Recalls Recalling Firm! Manufacturer Consumer Instructions For Additional Information Contact Reason for Recall Action Quantity in Commerce Distribution NGV451883H. NGV45189UH. NGV451898H NGV451904H NGV451923H. NGV451931H, NGV451941 H. NGV451948H. NGV451968H NGV451982H NGV451992H. NGV452001H. NGV45201 1H. NGV452220H. NGV452238H NGV452244H NGV452264H NGV452271H NGV452277H, NGV452284H. NGV452291H. NGV452297H NGV452305H NGV452314H. NGV452322H. NGV452329H. NGV452343H. NGV452351 H. NGV452367H NGV452377H NGV452393H NGV452410H. NGV452423H. NGV452532H. NGV452539H NGV452546H NGV452553H, NGV452551H. NGV452613H. NGV452623H. Medtronic. Inc. NGV451384H. NGV451885H. NGV451891H. NGV451892H. . NGV451899H. NGV451900H. . NGV451905H. NGV451908H. .NGV451914H.NGV451917H. NGV451924H. NGV451926H. NGV451933H. NGV451934H. NGV451942H. NGV451943H. NGV451951H thru NGV451962H. NGV451964H. NGV451965H, NGV451965H. . NGV451969H, NGV451971H. NGV451976H, NGV451977H. NGV451981 H. . NGV451984H. NGV451986H. NGV451988H, NGV451990H. NGV451991H. NGV451887H NGV451893H NGV451901H NGV451909H NGV45191BH NGV451928H NGV451936H NGV451944H .NGV451888H. .NGV451894H. .NGV451902H. .NGV451919H. NGV451929H. . NGV451937H. . NGV451945H. NGV451889H. NGV451396H, NGV451903H. NGV451912H. NGV451922H. NGV451930H, NGV451939H. NGV451947H, NGV451993H, NGV451994H, NGV451997H. NGV451998H. NGV451999H. NGV452002H. NGV452003H. NGV452008H. NGV452009H. NGV45201OH. NGV452213H. NGV452214H. NGV452215H. NGV452216H. NGV452219H. NGV452221H thru NGV452231H. NGV452233H. NGV452235H. NGV452235H. . NGV452239H. NGV452240H. NGV452241H. NGV452242H. NGV452243H. . NGV452246H tht'u NGV452259H. NGV452261H. NGV452262H. NGV452263H, . NGV452265H. NGV452266H, . NGV452272H. NGV452273H, NGV452279H. NGV452280H. NGV452285H. NGV452287H, NGV452292H. NGV452293H. . NGV452298H. NGV452299H. NGV452306H. NGV452307H. NGV452315H. NGV452316H. NGV452323H. NGV452324H. NGV452330H. NGV452333H, NGV452345H, NGV452347H. NGV452353H, NGV452359H. . NGV452370H, . NGV452379H, NGV452380H. . NGV452396H. NGV452397H. NGV452411H, NGV452412H. NGV452524H, NGV452527H. NGV452533H. NGV452534H. . NGV452542H. . NGV452547H. NGV452548H. NGV452554H. NGV452556H. NGV452563H thru NGV452584H. NGV452585H. NGV452587H. NGV452589H thru NGV452274H. NGV452281 H, NGV452288H. NGV452294H. NGV452300H. NGV452308H. NGV452317H. NGV452325H. NGV452336H. NGV45234BH. NGV452361 H. NGV452374H. NGV452384 H. NGV452405H. NGV452528H. NGV452535H, NGV4S2543H. NGV452549H. NGV452557H. NGV452269H NGV452415H NGV452558H . NGV452270H. . NGV452275H. NGV452282H. NGV452289H, NGV452295H. NGV452302H. NGV452309H. NGV452318H. NGV452326H. NGV452338H, NGV452349H. NGV452364H. NGV452375H. NGV452385H. NGV452407H. .NGV452416H. NGV452530H. NGV452536H. NGV452544H. NGV452550H. NGV452283H, NGV452290H. NGV452296H, NGV452304H. NGV452310H. MSW-152321 H. NGV452327H. NGV452340H. NGV452350H. NGV452355H. NGV452376H. NGV452390H. NGV452409H. NGV452531 H. NGV45253BH. NGV452545H. NGV452552H. . NGV452560H. NGV452615H. NGV452617H, NGV452620H. NGV452621H. AMENDED: NGV452898H, NGP360022H. NGP360204H. Neuromodulation 7000 Central Ave NE Minneapolis. Minnesota 55432-3568 Contact the recalling firm for information Medtronic Patient Services 800-510-6735 Medtronic is updating information regarding the potential for reduced battery performance that can lead to sudden loss of therapy in a small percentage of Medtronic Model 8647 ll pumps that was communicated with Healthcare providers in July 2009. The purpose of the current communication is to provide updated information regarding the scope and acourrence of this issue and to emphasize Medtronic Neuromodulation noti?ed physicians with an Urgent Medical Device Correction letter beginning July 05. 2011. A press was issued July 08. 2011. The letter described the issue. severity. recommendations if they notice issue. and patient management recommendations, UPDATE: in November 2011, MDT began to exchange unused pumps in inventory with pumps that contained the new battery. A letter dated November 2011 was left behind at locations in which the MDT representative swapped out the devices. 139.653 (105,002 US, 34.61 OUS) Woddwide including USA. Puerto Rico. Algeria. Aruba. Australia, Austria. Belarus. Belgium. Brazil. Chile. Colombia. Costa Rica. Croatia. Cyprus. Czech Republic. Denmark. Dominican Republic. Egypt. Finland. France. Germany. Greece. Hungary. Iceland. India. Iran Iraq. Ireland. Israel Italy, Jordan. Kuwait. Lebanon. Lithuania. Luxembourg. Malta. Martinique. Mexico. Morocco. Netherlands. Netherlands Antilles. New Caledonia. New Zealand. Norway. Panama. Poland. Portugal. Qatar. Reunion. Romania. Russian Federation. San Marino. Saudi Arabia. Serbia. Slovakia. Slovenia. South Africa. Spain. Sri Lanka. Sweden. Switzerland. Tunisia. Turkey. United Arab Emirates, United Kingdom. and Uruguay. Page 9 ofll 3/21/2013