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-1051-2016
  • 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=143781
  • 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 00000350495CN8 A5333025 00001001853YM9 AL4004CT01 00000953838YM0 AL4023CT01 00001001879YM4 0002876927 00000357924CN0 1577LS16 00001001879YM4 0002876927 00001001879YM4 0002876927 00001001879YM4 0002876927 00001010424YM8 0910212127 00001010461YM0 0910212129 00001010461YM0 0910212129 00001010471YM9 0910213084 00000980093YM9 0910212119 00000980093YM9 0910212119 00000994084YM2 0910212123X 00000984698YM1 0910213080 00001010387YM7 0910215023 00001010475YM0 0910215025 00001001897YM6 AH5703CT01 00000980120YM0 AH4001PE01 00000988410YM7 110002CT02 00000953828YM1 110017CT01 00000980106YM9 110040CT03 00000953853YM9 110059CT01 00000988410YM7 110002CT02 00000980111YM9 030355CT03 00000980111YM9 030355CT03 00001002103YM8 2858149 00000383739CN0 CT383739CN0 00000980108YM5 BF1012CT01 00000980108YM5 BF1012CT01 00000980108YM5 BF1012CT01 00000988391YM9 CT988391YM9 00000988391YM9 CT988391YM9 00000988391YM9 CT988391YM9 00001002107YM9 082421120191 00000364134CN7 082445160009 00000365398CN7 082445040002 00000363607CN3 082421100316 00001002106YM1 082421110048 00000953856YM2 082421120171 00001001852YM1 082421120187 00001010423YM0 082421100294 00001010444YM6 082421100301 00000941008YM5 082421020154 00000988393YM5 082421030172 00000996079YM0 082421030175 00000988398YM4 082421050047 00000996082YM4 082421100157 00000984688YM2 082421100270 00000988395YM0 082421100276 00000988397YM6 082421100278 00000984685YM8 082421100283 00001010426YM3 082421160169 00001010436YM2 082421160176 00000980095YM4 082421180052 00001010457YM8 082421180061 00001023062YM1 082421180064 00000984699YM9 082421010160 00000941008YM5 082421020154 00000994089YM1 082421100284 00001002104YM6 082421120188 00000984700YM5 082421130071 00000988386YM9 082421130073 00001010451YM1 082421100307 00001010455YM2 082421290042 00001010478YM4 EE1020CT01 00001010478YM4 EE1020CT01 00000953833YM1 FI1052CT02 00000994076YM8 A9885025 00000994074YM3 C2195260 00000994074YM3 C2195260 00000994076YM8 A9885025 00000994086YM7 GOLD010094 00000363551CN3 X265413001 00000988394YM3 M1612804 00000984701YM3 M2311502 00000994086YM7 GOLD010094 00001023052YM2 M4162509 00000953834YM9 M4189251 00000953830YM7 M4217029 00000953837YM2 M4400629 00001001899YM2 M4480007 00000980112YM7 M4490502 00000980094YM7 M4505261 00000997212YM6 M4854012 00001001883YM6 M6065310 00000994076YM8 A9885025 00000941016YM8 X100719101 00001023052YM2 M4162509 00000363551CN3 X265413001 00000365551CN3 X265413001 00001023056YM3 X706835004 00000363551CN3 X265413001 00000363551CN3 X265413001 00000984701YM3 M2311502 00000988394YM3 M1612804 00000997212YM6 M4854012 00001001883YM6 M6065310 00000994074YM3 C2195260 00000984701YM3 M2311502 00000997212YM6 M4854012 00001023052YM2 M4162509 00001001883YM6 M6065310 00000980117YM6 GOLD010585 00000980117YM6 GOLD010585 00001001860YM4 420127CT01 00001010403YM2 439532CT01 00001023050YM6 442365CT01 00000980113YM5 PROS01CT04 00001023051YM4 UHAN01CT07 00000980113YM5 PROS01CT04 00000980113YM5 PROS01CT04 00000988408YM1 393115CT01 00000953843YM0 408749CT01 UNK2378661-305 439532CT01 UNK23786610001 CC4821CT03 00000941024YM2 HC1649CT01 00000953843YM0 408749CT01 00000988384YM4 HC4912CT01 00000988382YM8 HC4912CT02 00000953855YM4 HC7946CT03 UNK23786610000 HC7946CT03 UNK2378661-305 439532CT01 00000988382YM8 HC4912CT02 00001001866YM1 PC0075CT05 00000988385YM1 PC0815CT05 UNK2378661-300 PC4176CT02 00000941022YM6 PSTU02CT06 00000953843YM0 408749CT01 00000980105YM1 UC1923CT05 00000941024YM2 HC1649CT01 00000980105YM1 UC1923CT05 00000941022YM6 PSTU02CT06 00000953855YM4 HC7946CT03 00000988384YM4 HC4912CT01 00001001878YM6 00257CTS04 00000953843YM0 408749CT01 00000953843YM0 408749CT01 00001001888YM5 H10632CT08 00001001888YM5 H10632CT08 00001001888YM5 H10632CT08 00001001888YM5 H10632CT08 00001001888YM5 H10632CT08 00001001886YM9 H2094CT11 00001023049YM8 H2112CT02 00000984691YM6 H5826CT01 00001010448YM7 0828210052 00001023047YM2 HU1114CT01 00000988402YM4 083021061102211 00001010441YM2 083021602200264 00000408732CN6 0002777955 00000408732CN6 0002777955 00000341516CN3 IL1020NM31 00000980121YM8 IL1082CT02 00000341516CN3 IL1020NM31 00000341516CT3 IL1082CT03 00001001875YM2 A5348207 00000994075YM0 A5258505 00000941013YM5 A257527001 UNK2378661-302 A5111130 00001010481YM8 A5118059 00000996077YM4 A5124913 00001001869YM5 A5128405 00000364957CN1 A5129956 00001001869YM5 A5128405 00001010476YM8 A5311007 00001023057YM1 A5379305 00001010440YM4 A5387105 00001001874YM5 A5618325 00001010473YM5 D5249901 00000953846YM3 A224857323 00000980115YM0 A5110016 UNK2378661-303 A5127399 00000984684YM1 A5131848 00000941018YM4 A5144908 00000953852YM1 A5164340 00000980115YM0 A5110016 00000364182CN6 A5215931 00000984692YM4 A5358103 00000988388YM5 A5361302 00000980116YM8 A5413819 00000980115YM0 A5110016 UNK2378661-304 B5343102 00000980114YM3 H5382003 00000941036YM6 QT3029 00000941014YM3 QT3030 00000941031YM7 QT3031 00000941033YM3 QT3032 00000953829YM9 QT3033 00000953850YM5 QT3034 00000953847YM1 QT3036 00000980100YM2 QT3037 00000980098YM8 QT3039 00000980096YM2 QT4049 00000980101YM0 QT4050 00000994079YM2 QT4051 00001001854YM7 QT4056 00001001855YM4 QT4057 00001010392YM7 QT4061 00000996072YM5 QT4062 00001010401YM6 QT4063 00001023043YM1 QT4065 00001023042YM3 QT4066 00001010416YM4 QT4077 00000953831YM5 QW3056 00000953849YM7 QW3057 00000980097YM0 QW3059 00000988399YM2 QW3064 00001001857YM0 QW3068 00001023044YM9 QW4087 00000953849YM7 QW3057 0000000G16ME01 QX0044 00000953827YM3 QY0012 00000980099YM6 QZ0001 00000941032YM5 QZ0021 00001023046YM4 SG0090 00000941035YM8 XF0010 00000941010YM1 XF0018 00000941025YM9 QT3027 00000941030YM9 QT3028 00000953832YM3 QT3035 00001023058YM9 QT3035 00000980103YM6 QT3040 00000980102YM8 QT3041 00000980107YM7 QT3042 00000941034YM1 QT3044 00000984686YM6 QT3045 00000984697YM3 QT3047 00000988400YM8 QT3048 00000996076YM6 QT4052 00000980110YM1 QT4054 00001001856YM2 QT4055 00001001895YM0 QT4058 00000988389YM3 QT4060 00001010452YM9 QT4064 00001023045YM6 QT4074 00001010449YM5 QV0030 00000941026YM7 QW3051 00000941028YM3 QW3060 00000941020YM0 QW3077 00000941023YM4 QW3078 00000988392YM7 QW3080 00001010453YM7 QW4088 00000988409YM9 QY0014 00000996073YM3 QY0041 00000980119YM2 QZ0020 00000941012YM7 XF0022 00000988404YM0 XF0149 00001010437YM0 0850210570 00001010439YM6 0850210572 00000984687YM4 0850210560 00000994072YM7 0850210562 00000941017YM6 KW1042CT01 00001023064YM7 KW1008CT03 00000941027YM5 KW1013CT01 00000941017YM6 KW1042CT01 00000941017YM6 KW1042CT01 00001010472YM7 LB1160CT01 00001010472YM7 LB1160CT01 00001010472YM7 LB1160CT01 00000953854YM7 LY1018CT01 00001010454YM5 0834210024 00001010454YM5 0834210024 00000354679KN3 314LS2543020 00001001867YM9 449CT2893654 00000361838CN6 44LS2551149 00000365448CN0 57CTLS16 00000953851YM3 MA1013CT02 UNK2378661-301 DVT0122 00001010463YM6 0920219033 00000361714CN9 0843210103 00001010432YM1 PL1019CT02 00001001885YM1 PL1235CT03 00001001885YM1 PL1235CT03 00001010460YM2 RU1078CT02 00001023060YM5 RU2526CT01 00001001898YM4 RU2705CT01 00000994077YM6 RU1158CT01 00001023065YM4 SA1387CT01 00000984683YM3 0847210020 00001001893YM5 ZA1071CT01 00000994088YM3 ZA1127CT02 00000994088YM3 ZA1127CT02 00001010442YM0 ZA2051CT01 00001023048YM0 ZA2244CT01 00001001891YM9 EPI28404 00000996081YM6 FPA99409 00001010462YM8 YP308712 00001010419YM8 082421140154 00001001858YM8 MPX30218 00001010446YM1 C003CT01 00001023063YM9 L006CT01 00000984694YM0 475230CT04 00000988396YM8 529170CT05 00000988396YM8 529170CT05 00000988396YM8 529170CT05 00000994078YM4 0853210154 00001010465YM1 01017CTS01 00001001892YM7 06013CTS01 00000953842YM2 38006CTS01 00001010406YM5 UK1085CT01 00000988387YM7 AE1021CT02 00001001878YM6 00257CTS04 00000980109YM3 00416CTS03 00000941019YM2 00432CTS03 00000953844YM8 00468CTS01 00000984693YM2 00664CTS02 00001001873YM7 01211CTS02 00001001872YM9 70365CTS03 00001001887YM7 00094CTS01 00000953835YM6 10470CTS01 00000953845YM5 10476CTS01 00000953848YM9 10479CTS01 00000988403YM2 10486CTS01 00001001896YM8 77266CTS02 00001001896YM8 77266CTS02 00000953841YM4 00314CTS02 00001010390YM1 941747LS16 00001010390YM1 941747LS16 00001010474YM3 928669CT 00001001861YM2 770638LS16 00001001861YM2 770638LS16 00000344959CN2 ZWL0470
  • 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
    LightSpeed 16 (MDAS only || , , 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