Events

Recall of Device Recall GE PET/CT System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by GE Medical Systems, LLC.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    73248
  • Event Risk Class
    Class 2
  • Event Number
    Z-1050-2016
  • Event Initiated Date
    2016-02-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-09-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143780
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, tomography, computed, emission - Product Code KPS
  • Reason
    Ge healthcare has updated the service manuals for a number of ct and pet ct scanners to update an incorrect torque value.
  • Action
    GE Healthcare sent an Urgent Medical Device Correction letter " GEHC Ref# 25467-ABT or 25467" dated February 12, 2016, to all affected consignees . The letter was addressed to Hospital Administrators / Risk Managers, Managers of Radiology/Cardiology, & Radiologist/Cardiologist. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. Consignees were instructed to ensure that the organization that service their equipment uses the latest version of the Service Manual to maintain the safe and proper performance of their medical device. For questions call in the United States: 1-800-437-1171 or your local GE Healthcare Service Representative. For questions regarding this recall call 262-513-4122.

Device

Device Recall GE PET/CT System
  • Model / Serial
    Mfg Lot or Serial # System ID 00000312256CN1 4860LS16GS 00000312256CN1 4860LS16GS 00000312256CN1 4860LS16GS 00000294153CN2 0910212097 00000309306CN9 0910212101 00000309960CN3 0910212104 00000309960CN3 0910212104 00000311052CN5 0910212105 00000321402CN0 0910212106 00000321402CN0 0910212106 00000337340CN4 0910212115 00000337340CN4 0910212115 00000337340CN4 0910212115 00000297003CN6 0910213064 00000313645CN4 0910213070 00000301209CN3 0910215018 00000313097CN8 0910216036 00000337344CN6 0910216041 00000297460CN8 AH1410CT06 00000325191CN5 AH5362CT02 00000310728CN1 110037CT01 00000310728CN1 110037CT01 00000299935CN7 190020CT03 00000311058CN2 190052CT06 00000297386CN5 190059CT04 00000311058CN2 190052CT06 00000311426CN1 030018CT01 00000297596CN9 BA4142CT01 00000297596CN9 BA4142CT01 00000297596CN9 BA4142CT01 00000327271CN3 10026 00000346702CN4 1350651 00000310682CN0 2850998 00000310682CN0 2850998 00000327815CN7 CT327815CN7 00000332075CN1 BG4037CT01 UNK23399850000 BG4037CT01 00000316663CN4 BG4042CT01 00000316663CN4 BG4042CT01 00000327081CN6 BG4608CT01 00000314635CN4 BG4600CT01 00000357475CN3 CM1007CT02 00000357475CN3 CM1007CT02 00000357475CN3 CM1007CT02 00000361978CN0 082445020003 00000361978CN0 082445020003 00000361978CN0 082445020003 00000352887CN4 082445030003 00000347756CN9 082445100008 00000347756CN9 082445100008 00000309961CN1 082445150001 00000336259CN7 082445150008 00000359854CN7 082445160007 00000354676CN9 082445250002 00000294148CN2 HLGSCTD10002 00000294148CN2 HLGSCTD10002 00000299483CN8 082421111101 00000334898CN4 082421140150 00000322331CN0 082421160145 00000298653CN7 082421030115 00000333002CN4 082421030162 00000295411CN3 082421030340 00000299934CN0 082421040093 00000295644CN9 082421040096 00000299483CN8 082421111101 00000308733CN5 082421040103 00000299951CN4 082421030354 00000299951CN4 082421030354 00000299951CN4 82421030354 00000322333CN6 082421040120 00000295409CN7 082421050034 00000323331CN9 082421050038 00000343124CN4 082421060040 00000317099CN0 082421070116 00000330529CN9 082421070130 00000297900CN3 082421070368 00000323328CN5 082421080059 00000320550CN7 082421100258 00000323310CN3 082421100259 00000322857CN4 082421100260 00000322857CN4 082421100260 00000335318CN2 082421100265 00000336002CN1 082421130067 00000329307CN3 082421160152 00000342614CN5 082421160155 00000295117CN6 082421210084 00000319305CN9 082421220038 00000297900CN3 082421070368 00000331165CN1 082421010103 00000335317CN4 082421010157 00000333000CN8 082421020090 00000287474CN1 082421130055 00000295411CN3 082421030340 00000308614CN7 082421130065 00000336002CN1 082421130067 00000314492CN0 082421140117 00000356887CN0 082421220038 00000336001CN3 082421220044 00000323308CN7 082421020070 00000332999CN2 082421140145 00000295644CN9 082421040096 00000346880CN8 2532905LIG16 00000337342CN0 374521381CT 00000337342CN0 374521381CT 00000295118CN4 DK1018CT01 00000297992CN0 DK1025CT02 00000313915CN1 11390744CT 00000313915CN1 11390744CT 00000323858CN1 FI1003CT03 00000295643CN1 FI1017CT02 00000323858CN1 FI1003CT03 00000295643CN1 FI1017CT02 00000304685CN1 A4167313 00000319308CN3 B4195716 00000313650CN4 C6010809 UNK23399850001 GOLD001266 00000298318CN7 GOLD010093 00000310120CN1 X966077004 00000313650CN4 C6010809 00000324460CN5 M1020808 00000326112CN0 M1279722 00000311808CN0 M2312304 00000293009CN7 M2322212 00000307022CN4 M23737001 00000311059CN0 M2486504 00000305523CN3 M2800910 00000317193CN1 M2848414 00000298344CN3 M40345153 00000298327CN8 M4047054 00000298318CN7 GOLD010093 00000320672CN9 M4160064 00000303583CN9 M4163021 00000324985CN1 M4174504 00000298659CN4 M4180123 00000310268CN8 M4191025 00000326084CN1 M4192518 00000325672CN4 M4198036 00000326326CN6 M4198185 00000304683CN6 M4215536 00000336000CN5 M4409416 00000336003CN9 M4491526 00000309305CN1 M4491923 00000319062CN6 M4497247 00000302751CN3 M4516011 00000293499CN0 M5481223 00000315232CN9 M5647104 00000326111CN2 M8050904 00000296278CN5 M9202219 00000297389CN9 M9481828 00000297389CN9 M9481828 00000315232CN9 M5647104 00000305523CN3 M2800910 00000297001CN0 270494CT02 00000310266CN2 X751962001 00000311422CN0 X90281601 00000318593CN1 X965468001 00000319063CN4 X976365001 00000322856CN6 X98683601 00000329304CN0 X993729001 00000336000CN5 M4409416 00000325672CN4 M4198036 00000304683CN6 M4215536 00000298327CN8 M4047054 00000311059CN0 M2486504 00000336000CN5 M4409416 00000329304CN0 X993729001 00000319063CN4 X976365001 00000309305CN1 M4491923 00000317193CN1 M2848414 00000307022CN4 M23737001 00000324985CN1 M4174504 00000319062CN6 M4497247 00000298659CN4 M4180123 00000311422CN0 X90281601 00000326111CN2 M8050904 00000319062CN6 M4497247 00000319062CN6 M4497247 00000311059CN0 M2486504 00000298327CN8 M4047054 00000307022CN4 M23737001 00000304683CN6 M4215536 00000324985CN1 M4174504 00000304683CN6 M4215536 00000329303CN2 GOLD010082 00000329303CN2 GOLD010082 00000329303CN2 GOLD010082 00000309522CN1 GOLD001588 00000297427CN7 GOLD001604 00000293010CN5 GOLD002151 00000319948CN6 GOLD002182 00000293010CN5 GOLD002151 00000297427CN7 GOLD001604 00000319948CN6 GOLD002182 00000309522CN1 GOLD001588 00000296977CN2 410014CT01 00000288652CN1 CC0618CT02 00000313361CN8 HC0399CT01 00000301205CN1 HC1627CT04 00000310261CN3 HC2252CT01 00000294145CN8 HC3076CT01 00000302750CN5 HC3314CT02 00000327818CN1 HC4438CT01 00000311056CN6 PC1268CT03 00000317102CN2 PC1401CT01 00000302754CN7 PC7479CT02 00000299235CN2 PC8118CT03 00000294146CN6 UC1590CT01 00000296977CN2 410014CT01 00000310261CN3 HC2252CT01 00000294146CN6 UC1590CT01 00000302754CN7 PC7479CT02 00000309302CN8 HC3428CT02 00000310261CN3 HC2252CT01 00000302754CN7 PC7479CT02 00000305953CN2 05252CTS01 00000305953CN2 05252CTS01 00000294146CN6 UC1590CT01 00000327079CN0 GP1036CT01 00000297599CN3 0828210042 00000309521CN3 0828210045 00000322338CN5 0828210046 00000330530CN7 0828210047 00000323258CN4 0828210094 00000323258CN4 0828210094 00000325192CN3 HU1137CT02 00000319061CN8 Unlocated 00000317789CN6 GOLD010275 00000313648CN8 HU1008CT02 00000297465CN7 HU1039CT03 00000297465CN7 HU1039CT03 00000300567CN5 083021840009012 00000331758CN3 08302100210134X 00000342119CN5 083021042101703 00000345300CN8 083021242100044 00000307945CN6 083021592012120 00000332732CN7 083021602101433 00000311812CN2 083021802100123 00000331758CN3 08302100210134X 00000336854CN5 083021824542213 00000322337CN7 083021842100841 00000336854CN5 083021824542213 00000333821CN7 IR1050CT02 00000330534CN9 IL1000CT01 00000314489CN6 A5816714 00000298365CN8 A206873404 00000294150CN8 A224457303 00000314489CN6 A5816714 00000298364CN1 A5109820 00000329300CN8 A5114983 UNK23399850002 A5127399 00000297387CN3 A5158020 00000298788CN1 A5248810 00000297006CN9 A5279809 00000297467CN3 A5315535 00000305241CN2 A5333021 00000325670CN8 A5364424 00000318594CN9 A5366613 00000297991CN2 A5375119 00000297991CN2 A5375119 00000298788CN1 A5248810 00000308141CN1 A5630204 00000314489CN6 A5816714 00000296974CN9 A5824009 00000316659CN2 A95819201 00000297991CN2 A5375119 00000308982CN8 QW2001 00000294505CN3 QW2006 00000295885CN8 QW2007 00000294505CN3 QW2006 00000304155CN5 QW2021 00000304690CN1 QW2023 00000304692CN7 QW2024 00000305242CN0 QW2025 00000307953CN0 QW2026 00000305954CN0 QW2027 00000305522CN5 QW2028 00000310727CN3 QW3032 00000303514CN4 QW3033 00000311054CN1 QW3036 00000304691CN9 QW3037 00000310876CN8 QW3039 00000303582CN1 QW3040 00000313918CN5 QW3042 00000317976CN9 QW3044 00000309301CN0 QW3045 00000314632CN1 QW3052 00000324987CN7 QW3054 00000325671CN6 QW3055 00000320665CN3 QW3058 00000331765CN8 QW3070 00000304158CN9 QY0002 00000297463CN2 QY0006 00000310122CN7 QY0058 00000313651CN2 QZ0064 00000352579CN7 YE0201 00000357355CN7 YE0202 00000361979CN8 YE0203 00000354674CN4 YE0205 00000365101CN5 YE0210 00000366340CN8 YE0211 00000348807CN9 YE0214 00000293890CN0 QW2002 00000292947CN9 QW2004 00000294768CN7 QW2005 00000298654CN5 QW2009 00000297005CN1 QW2010 00000299761CN7 QW2012 00000298655CN2 QW2013 00000301085CN7 QW2014 00000301207CN7 QW2015 00000295646CN4 QW2018 00000299762CN5 QW2019 00000301206CN9 QW2022 00000310264CN7 QW2029 00000307949CN8 QW3031 00000313364CN2 QW3041 00000297007CN7 QW3043 00000322855CN8 QW3047 00000326660CN8 QW3047 00000321451CN7 QW3048 00000322120CN7 QW3048 00000326662CN4 QW3053 00000297005CN1 QW2010 00000298361CN7 QX0014 00000297007CN7 QW3043 00000297007CN7 QW3043 00000303436CN0 QY0017 00000296978CN0 QY0044 00000301211CN9 QZ0006 00000298785CN7 QZ0008 00000294147CN4 QZ0009 00000293891CN8 QZ0036 00000295415CN4 QZ0039 00000297597CN7 SG0033 00000292948CN7 XG0009 00000354889CN8 YE0204 00000305243CN8 QW3034 00000305243CN8 QW3034 00000348807CN9 YE0214 00000311418CN8 JO1000CT02 00000298652CN9 JO1009CT03 00000298652CN9 JO1009CT03 00000307946CN4 ZA6002CT02 00000295412CN1 0850210523X 00000295413CN9 0850210532 00000309310CN1 0850210548X 00000314641CN2 0850210549 00000323317CN8 0850210550X 00000329993CN0 0850210825 00000329305CN7 0850210552 00000335459CN4 0850210554 00000332082CN7 0850210555 00000334466CN0 0850210873 00000334880CN2 0850210557 00000336853CN7 0850210558X 00000336257CN1 0850210837 00000329993CN0 0850210825 00000336257CN1 0850210837 00000334466CN0 0850210873 00000322332CN8 KW1012CT02 00000321964CN9 LB1050CT01 00000309523CN9 110807CT01 00000294851CN1 0834210019 00000294851CN1 0834210019 00000294502CN0 CT294502CN0 00000346391CN6 2535997DST 00000346391CN6 2535997DST 00000359395CN1 2546945DST 00000295414CN7 73801LS16S 00000294502CN0 CT294502CN0 00000294502CN0 CT294502CN0 00000307947CN2 NO1052CT02 00000293035CN2 OM1043CT01 00000293035CN2 OM1043CT01 00000297995CN3 0843210037 00000301208CN5 0843210038 00000343087CN3 0843210116 00000343087CN3 0843210116 00000298359CN1 600042CT01 00000305951CN6 600062CT01 00000298359CN1 600042CT01 00000305951CN6 600062CT01 00000314495CN3 PPR56604 00000314495CN3 PPR56604 00000314495CN3 PPR56604 00000314493CN8 809780LS16 00000310681CN2 809740LS16 00000297897CN1 RE1001CT02 00000297897CN1 RE1001CT02 00000328357CN9 RU2116CT01 00000296276CN9 SA1011CT02 00000328360CN3 SA1012CT08 00000328359CN5 SA1007CT03 00000317094CN1 SA1014CT02 00000310875CN0 SA1279CT01 00000001380806 0847210020 00000001380806 0847210020 00000303589CN6 SK1003CT01 00000327082CN4 SK1056CT01 00000323315CN2 ZA1000CT02 00000323315CN2 ZA1000CT02 00000310270CN4 ZA1247CT01 00000318926CN3 ZA1442CT02 00000314636CN2 ZA2103CT01 00000314636CN2 ZA2103CT01 00000295879CN1 UPW00600 00000308732CN7 082421160123 00000329306CN5 DE188430 00000327272CN1 DEL26410 00000329991CN4 DEL89957 00000329991CN4 DEL89957 00000309308CN5 DEN27243 00000297385CN7 DPB15832 00000293038CN6 DPC32410 00000030411CN8 DPM32132 00000313369CN1 DPM99916 00000297902CN9 FPG03601 00000305945CN8 FPG03720 00000304109CN2 FPG08400 00000305945CN8 FPG03720 00000330699CN0 FPG79903 00000310874CN3 MPX02003 00000329992CN2 NP739714 00000294144CN1 NPV13924 00000310874CN3 MPX02003 00000294144CN1 NPV13924 00000294144CN1 NPV13924 00000297902CN9 FPG03601 00000295879CN1 UPW00600 00000313369CN1 DPM99916 00000304109CN2 FPG08400 00000293038CN6 DPC32410 00000304109CN2 FPG08400 00000295879CN1 UPW00600 00000293038CN6 DPC32410 00000297902CN9 FPG03601 00000313369CN1 DPM99916 00000299766CN6 A010CT07 00000311423CN8 A010CT08 00000325188CN1 A010CT09 00000354675CN1 C011PE01 00000323859CN9 259130CT02 00000297002CN8 260010CT13 00000297002CN8 260010CT13 00000304112CN6 426020CT02 00000323859CN9 259130CT02 00000323859CN9 259130CT02 00000296274CN4 501030CT02 00000297466CN5 529040CT01 00000296274CN4 501030CT02 00000313362CN6 899010CT02 00000346701CN6 900010PE08 00000297002CN8 260010CT13 00000346701CN6 900010PE08 00000296274CN4 501030CT02 00000304112CN6 426020CT02 00000304112CN6 426020CT02 00000299949CN8 0853210138 00000312925CN1 0853210142 00000312925CN1 0853210142 00000318883CN6 0853210145 00000318883CN6 0853210145 00000328912CN1 0853210150 00000338965CN7 0853450020 00000346743CN8 0853450023 00000354795CN7 0853450038 00000354795CN7 0853450038 00000359858CN8 0853450062 00000298792CN3 TN1013CT03 00000298319CN5 TN1006CT03 00000294852CN9 TN1168CT01 00000310879CN2 AE1005CT02 00000310879CN2 AE1005CT02 00000305239CN6 05006CTS01 00000307948CN0 05027CTS03 00000305953CN2 05252CTS01 00000293032CN9 00243CTS05 00000293032CN9 00243CTS05 00000294856CN0 00361CTS02 00000318595CN6 00537CTS01 00000294042CN7 00557CTS01 00000305952CN4 01051CTS02 00000293032CN9 00243CTS05 00000300489CN2 00020CTS01 00000299314CN5 00095CTS01 00000312924CN4 00160CTS02 00000311813CN0 00257CTS02 00000314497CN9 10079CTM62 00000294343CN9 10441CTS01 00000312815CN4 10458CTS01 00000311420CN4 70050CTS02 00000313653CN8 70328CTS03 00000310732CN3 80040CTS02 00000322119CN9 01027CTS01 00000323259CN2 00432CTS03 00000295880CN9 00298CTS07 00000305524CN1 00216CTS04 00000298358CN3 00133CTS02 00000310262CN1 PM1633CT04 00000311810CN6 763588SPCT 00000336801CN6 936538PERC 00000316259CN1 210351MSDLS 00000328245CN6 706378LS16 00000304684CN4 714633CTM 00000294765CN3 251368ACT 00000316660CN0 402887CT16 00000293034CN5 419584CT 00000318591CN5 309680CT 00000317568CN4 214647LS16 00000336801CN6 936538PERC 00000318591CN5 309680CT 00000316660CN0 402887CT16 00000293034CN5 419584CT 00000317568CN4 214647LS16 00000294765CN3 251368ACT 00000316259CN1 210351MSDLS 00000311810CN6 763588SPCT 00000328245CN6 706378LS16 00000294345CN4 SMGCT15 00000296976CN4 38826196CTOCC 00000296976CN4 38826196CTOCC  00000323258CN #N/A
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US including all states in including PR except ND, VT & WY. Foreign Distribution: ALBANIA, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BOSNIA & HERZEGOVINA, BRAZIL, BULGARIA, BURKINA FASO, CAMERON, CANADA, CHILE, CHINA, COLOMBIA, DOMINICAN REPUBLIC, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, GUADELOUPE,HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRA N, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KENYA, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, LUXEMBOURG, MALAYSIA, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, PERU, PHILIPPINES, POLAND, PORTUGAL, REUNION, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, TUNISIA, TURKEY, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA .
  • Product Description
    Discovery ST, , 2339985 || LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications. PET Discovery ST system - The GE Discovery ST system is intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery ST is to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. This device can also assist in radiotherapy planning. The Discovery ST system can also be used as a stand-alone head and whole body multi-slice computed tomography (CT) diagnostic imaging system. LightSpeed Pro16 - The Lightspeed 5.0 CT Scanner System is indicated for head and whole body X-ray computed tomography applications. 16 Slice BGO PET/CT System - The GE Discovery XR and XA Systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery XR and XA are to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. These devices can also assist in radiotherapy planning. The Discovery XR and XA can also be used as stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging systems. 6 Slice BGO PET/CT System - The GE Discovery LS System is intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery LS is to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. This device can also assist in radiotherapy planning. The Discovery LS can also be used as a stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging system.
  • Manufacturer
    GE Medical Systems, LLC

Manufacturer

GE Medical Systems, LLC
  • Manufacturer Address
    GE Medical Systems, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Manufacturer Parent Company (2017)
    General Electric Company
  • Source
    USFDA