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-1049-2016
  • Event Initiated Date
    2016-02-10
  • Event Status
    Terminated
  • Event Country
  • Event Terminated Date
    2016-09-21
  • Event Source
    USFDA
  • Event Source URL
  • 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

  • Model / Serial
    Mfg Lot or Serial # System ID 00000002631PT0 4860AW442 00000002631PT0 4860AW442 00000318118CN7 0910213115 00000002808PT4 0910453003P 00000318118CN7 0910213115 00000318118CN7 0910213115 00000980093YM9 0910212119 00000002247PT5 090016PT01 00000326200CN3 110012CT01 00000311426CN1 030018CT01 00000002103PT0 2728449 00000003306PT8 2757760XXX 00000003306PT8 2757760XXX 00000003310PT0 47867 00000002103PT0 2728449 00000002103PT0 2728449 00000339630CN6 BG4029CT01 00000298328CN6 204787LS1 00000298660CN2 204787LSPD2 00000307018CN2 416249LS16 00000309304CN4 519744LS16 00000309524CN7 819379LS 00000310680CN4 418862LS 00000312264CN5 450656LS 00000316257CN5 613761LS16 00000317195CN6 604988LS16 00000318444CN7 514499LS 00000318927CN1 514468BLS 00000319310CN9 519421LS16 00000324459CN7 450466LS 00000328940CN2 450654LS 00000329994CN8 819561LS 00000332076CN9 506648LS16 00000335314CN1 514934CLS16 00000341799CN5 416284LS16 00000341801CN9 416744LS16 00000341802CN7 905883LS16 00000347191CN9 450778LS 00000348810CN3 416924DST 00000349405CN1 514934BDST 00000994091YM7 418549LS 00000334561CN8 26329CT4X 00000002642PT7 082445310001 00000002660PT9 082445310003 00000340577CN6 082421120176 00000340630CN3 082421140148 00000989604YM4 082421030247 00000989603YM6 082421040128 00000989606YM9 082421080068 00000989606YM9 082421080068 00000989602YM8 082421100277 00000989607YM7 082421210116 00000352887CN4 USONCDST16 00000346880CN8 2532905LIG16 00000295643CN1 FI1017CT02 00000334897CN6 A9190135 00000001843PT2 B4155412 00000334897CN6 A9190135 00000002494PT3 GOLD010013 00000341585CN8 GOLD010316 00000336468CN4 M4143946 00000002494PT3 GOLD010013 00000339849CN2 M4215541 00000339849CN2 M4215541 00000336833CN9 M4434860 00000341585CN8 GOLD010316 00000341585CN8 GOLD010316 00000341585CN8 GOLD010316 00000001843PT2 B4155412 00000293499CN0 M5481223 00000302751CN3 M4516011 00000309305CN1 M4491923 00000310268CN8 M4191025 00000313650CN4 C6010809 00000326112CN0 M1279722 00000329304CN0 X993729001 00000980112YM7 M4490502 00000317863CN9 GOLD002055 00000297427CN7 GOLD001604 00000031399CN5 CC0618CT03 00000313999CN5 CC0618CT03 00000988382YM8 HC4912CT02 00000330530CN7 0828210047 00000339850CN0 IS1001CT01 00000339850CN0 IS1001CT01 00000002861PT3 0002740730 00000002861PT3 0002740730 00000002861PT3 0002740730 00000334896CN8 0835210046X 00000002164PT2 IL1020NM18 00000980121YM8 IL1082CT02 00000002389PT5 A5128738 UNK22863270001 A5148558 00000317806CN8 A5152959 00000334895CN0 A5177358 00000325622CN9 A5269709 00000334875CN2 A5696306 00000003599PT8 A5645905 00000339627CN2 B5119111 00000339627CN2 B5119111 00000002207PT9 C5126802 00000003008PT0 YH0011 00000003080PT9 YH0012 00000002826PT6 YH0015 00000002969PT4 YH0016 00000003247PT4 YH0017 00000003662PT4 YH0019 00000003973PT5 YH0025 00000003972PT7 YH0026 00000004113PT7 YH0028 00000003102PT1 YN1033 00000327052CN7 QV0023 00000989605YM1 XF0149 00000001950PT5 YH0008 00000002711PT0 YH0010 00000002664PT1 YH0014 00000003663PT2 YH0020 00000003733PT3 YH0020 00000003733PT3 YH0020 00000003734PT1 YH0022 00000003732PT5 YH0023 00000004107PT9 YH0033 00000292947CN9 QW2004 00000294147CN4 QZ0009 00000294768CN7 QW2005 00000298361CN7 QX0014 00000298654CN5 QW2009 00000298785CN7 QZ0008 00000301211CN9 QZ0006 00000303436CN0 QY0017 00000307949CN8 QW3031 00000313364CN2 QW3041 00000988392YM7 QW3080 00000941023YM4 QW3078 00000941023YM4 QW3078 00000953832YM3 QT3035 00000980119YM2 QZ0020 00000345972CN4 0850210561 00000339481CN4 LV4000CT01 00000002663PT3 LB1077MN01 00000318890CN1 LT4000CT01 00000328801CN6 LT4001CT01 00000345987CN2 030013CT04 00000324061CN1 NO1016CT04 00000324061CN1 NO1016CT04 00000002442PT2 0843450002 00000338649CN7 PPR05009 00000002051PT1 MPX33107 00000339848CN4 O005CT06 00000315961CN3 Z001CT02 00000327581CN5 Z001CT02 00000345782CN7 120928CT01 00000314376CN5 260010CT13 00000002163PT4 529150PE01 00000315054CN7 547090CT05 00000345782CN7 120928CT01 00000314530CN7 725030CT01 00000341587CN4 794130CT02 00000002163PT4 529150PE01 00000315054CN7 547090CT05 00000296274CN4 501030CT02 00000323859CN9 259130CT02 00000346701CN6 900010PE08 00000003006PT4 0853450002 00000003004PT9 0853450003 00000002699PT7 0853450004 00000309505CN6 00243CTS06 00000309505CN6 00243CTS06 00000309505CN6 00243CTS06 00000003709PT3 10094PTM62 UNK22863270000 10094PTM62 00000003709PT3 10094PTM62 00000312815CN4 10458CTS01 00000318595CN6 00537CTS01 00000317863CN9 GOLD002055 00000341584CN1 315329CT16 00000341584CN1 315329CT16 303586CN2 SHICT24 311423CN8 559686DGCT1 309307CN7 SHICT18 318593CN1 MHOPSPLS16 297597CN7 MHOPFWCT1 311813CN0 281283MCLCT 311057CN4 713MHNWLS16 298358CN3 912486GECT 00000334468CN6 361PRMPKDL 304685CN1 210572TOLS16 329303CN2 MPXLS16 00000341884CN5 SHICT66 342627 509575YM16CT 00000277800CN9 415723SCT3 00000284984CN2 630352DST 00000288654CN7 703385LS16 00000292531CN1 423272CT 00000293011CN3 CT81441 00000293033CN7 CDISCT1 00000293034CN5 419584CT 00000293036CN0 352597PET 00000293037CN8 631475LS16 00000294043CN5 919BCLS16 00000294051CN8 312266L16 00000294344CN7 504873TL16 00000294345CN4 SMGCT15 00000294503CN8 770718OCT1 00000294504CN6 949760CT2 00000294506CN1 315464CT16 00000294765CN3 251368ACT 00000294766CN1 402481BWCT1 00000294857CN8 512AERNCT 00000294858CN6 RADNETCT443 00000294996CN4 404616QXI 00000295003CN8 561989CT4 00000295004CN6 509946LSCT 00000295005CN3 785452SCT 00000295006CN1 404732QXI 00000295116CN8 302738LS16 00000295119CN2 608263CT1 00000295120CN0 225769RGLS1 00000295121CN8 469525DLS 00000295122CN6 713932MCT3 00000295123CN4 814238LS1 00000295124CN2 502560ULT3 00000295125CN9 662841CT1 00000295410CN5 919731CT16 00000295416CN2 314768SMCT 00000295418CN8 903ADVCT16 00000295641CN5 920568CT16 00000295642CN3 805988GICT 00000295882CN5 727372LS16 00000295883CN3 704487LS16 00000295884CN1 916RICCT16 00000296271CN0 414541QXI4 00000296272CN8 518828CT 00000296275CN1 214705FCER 00000296277CN7 225761CT1 00000296279CN3 949631CT1 00000296280CN1 805SVCT1 00000297008CN5 415929KCT 00000297382CN4 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913676SLS16 00000299487CN9 586493H16 00000299763CN3 208467CTLS 00000299764CN1 FHOMPOPC1 00000299765CN8 703578LS16 00000299767CN4 850434BCT1 00000299768CN2 409899LS03 00000299933CN2 SHICT251 00000299950CN6 858939CT1 00000299954CN8 RADNETCT1447 00000300246CN6 704783LS16 00000300247CN4 515263CT1 00000300371CN2 573635SMCT2 00000300373CN8 702877CT1 00000300374CN6 503674CT 00000300490CN0 ALLIANCECT136 00000300854CN7 605882CT 00000300855CN4 702228CT 00000301082CN4 718334LS01 00000301083CN2 903594OLS 00000301084CN0 914737CTLS 00000301086CN5 312423LS16 00000302752CN1 718334LS02 00000303081CN6 913588KQXI 00000303515CN1 662841CT3 00000303581CN3 513867CT 00000303584CN7 301759CT16 00000303585CN4 651254CT3 00000303588CN8 973926LS16 00000303590CN4 404321QXI 00000304110CN0 303427LS1 00000304113CN4 276666CT 00000304156CN3 87FERMANCT 00000304157CN1 602277CT16 00000304159CN7 805988PET1 00000304684CN4 714633CTM 00000304687CN7 970244AMPCT 00000304688CN5 708342LS16 00000305240CN4 SHICT60 00000305525CN8 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  • Product Classification
  • 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 LS, 2286327 || 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

Manufacturer

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