Events

Recall of Device Recall Lightspeed 16 CT

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

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
    71842
  • Event Risk Class
    Class 2
  • Event Number
    Z-2801-2015
  • Event Initiated Date
    2015-07-17
  • Event Date Posted
    2015-09-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-03-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139199
  • 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, x-ray, tomography, computed - Product Code JAK
  • Reason
    Potential for expulsion of the power supply on lightspeed ct scanner or discovery st pet ct or discovery ls pet ct scanner.
  • Action
    GE Healthcare sent an "Urgent Medical Device Correction" letter to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. GE Healthcare will correct all affected products at no cost to you. A GE Healthcare representative will contact you to arrange for the correction. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative. Ref# 25463

Device

Device Recall Lightspeed 16 CT
  • Model / Serial
    00000058433HM4 4860LS16GS FMI25463004 910213080 FMI25463005 910212101 FMI25463006 910212105 FMI25463007 910213064 FMI25463008 910216041 FMI25463009 910216036 00000321402CN0 910212106 00000325191CN5 AH5362CT02 FMI25463010 190020CT03 FMI25463011 110807CT01 00000980106YM9 110040CT03 00000307018CN2 416249LS16 00000298660CN2 204787LSPD2 00000318927CN1 514468BLS 00000329994CN8 819561LS 00000389961CN4 709891CT 00000335314CN1 514934CLS16 00000340630CN3 82421140148 00000331165CN1 82421010103 00000336002CN1 82421130067 00000334898CN4 82421140150 00000322331CN0 82421160145 00000999187YM8 82421100291 FMI25463133 828210047 FMI25463136 82421310073 00000989604YM4 82421030247 FMI25463015 82421010063 00000075153HM7 82421120171 FMI25463016 082421ATCLSP04 FMI25463017 82421100443 00000080677HM8 82421090111 00000092789HM7 82421120191 00000092771HM5 82421120188 00000074379HM9 82421060038 FMI25463018 82421130055 00000092530HM5 82421110048 00000080298HM3 82421100270 FMI25463019 395291CT01 FMI25463020 PM1633CT04 FMI25463021 PC7479CT02 FMI25463022 DK1025CT02 00000420281CN8 NP384114 FMI25463023 FI2000MN01 00000953833YM1 FI1052CT02 FMI25463024 C6010809 FMI25463025 M1076839 FMI25463026 M40345153 FMI25463027 M4496936 FMI25463028 M4409416 FMI25463029 M2147233 FMI25463030 M4505261 FMI25463031 M4020535 FMI25463032 M4491526 FMI25463033 M2802781 FMI25463034 X971285001 FMI25463035 A4463317 FMI25463036 B4195716 00000320672CN9 M4160064 00000271501CN9 M4182817 00000302750CN5 HC3314CT02 00000311056CN6 PC1268CT03 00000980113YM5 PROS01CT04 00000309302CN8 HC3428CT02 00001033124YM7 HC1560CT05 00000031399CN5 CC0618CT03 00000301205CN1 HC1627CT04 00000000716YC1 PX2261CT02 FMI25463041 GOLD010271 FMI25463042 GOLD010160 00000297465CN7 HU1039CT03 00000313648CN8 HU1008CT02 FMI25463043 835210046 FMI25463045 83021842100841 00000475152YM5 83097598280000 FMI25463046 83021002101343 FMI25463047 83021002101503 FMI25463048 83037594099999 00000342119CN5 83021042101703 00000319062CN6 83021200019012 00000326255CN7 83021002100903 FMI25463134 IL1041CT01 FMI25463044 IL1000CT01 FMI25463049 A5177356 00000974327YM9 A5415714 FMI25463050 A5375119 00000297467CN3 A5315535 00000298788CN1 A5404503 00000298327CN8 A103421302 00000317806CN8 A5152959 00000298364CN1 A5109820 00000317976CN9 QW3044 00000277446CN1 QY0024 00000941020YM0 QW3077 00000311054CN1 QW3036 00000953849YM7 QWZ057 00000941010YM1 XF0018 00000953829YM9 QT3033 00000980097YM0 QW3059 00000305242CN0 QW2025 00000988399YM2 QW3064 00000297463CN2 QY0006 00000953847YM1 QT3036 00000304158CN9 QY0002 00000310122CN7 QY0058 00000980099YM6 QZ0001 00000941033YM3 QT3032 00000303514CN4 QW3033 00000988404YM0 XF0149 00000994079YM2 QT4051 00000980096YM2 QT4049 00000941031YM7 QT3031 00000328077CN3 QW3045 425784CN6 HD0041 33373GM2 RY0028 239249HM6 BD9217 FMI25463051 QT4074 FMI25463052 QT3042 FMI25463053 XF0022 FMI25463054 QW3049 00000296397CN3 QW2016 FMI25463055 QZ0120 00000004875YC1 QZ0066 FMI25463056 YN0382 FMI25463057 QW3057 00000297397CN2 QW3043 00001023672YM7 QW3073 00000314641CN2 850210549 00000067961HM3 850210557 00000071678HM7 850210558 00000086904HM0 850210826 00000066382HM3 850210555 00000392647CN4 LSPRO2643765 00000295414CN7 73801LS16S 00000307947CN2 NO1052CT02 00000286517CN8 604853CTLS FMI25463135 600042CT01 FMI25463058 809780EXCITE FMI25463059 SA1279CT01 00000296276CN9 SA1011CT02 FMI25463060 Z001CT02 1380806 847210020 00000303589CN6 SK1003CT01 00000310270CN4 ZA1247CT01 00000994088YM3 ZA1127CT02 00000318926CN3 ZA2471CT01 00000205583HM8 ZA1058CT02 00000309308CN5 DEN27243 00000030411CN8 DPM32132 00000329991CN4 DEL89957 00000329306CN5 DE188430 00000310874CN3 MPX02003 00000327272CN1 DEL26410 00000297385CN7 DPB15832 00000304109CN2 FPG08400 00000297902CN9 FPG03601 00000279527CN6 FPG81004 00000299766CN6 A010CT07 00001033115YM5 547110CT02 FMI25463012 475230CT04 FMI25463013 120928CT01 FMI25463014 115030CT01 00000312924CN4 00160CTS02 00000336000CN5 10649CTS01 00000294856CN0 00361CTS02 00000984693YM2 00664CTS02 00000302754CN7 10628CTS01 313653CN8 70328CTS03 FMI25463037 00537CTS01 FMI25463038 80040CTS02 FMI25463039 00314CTS02 FMI25463040 10470CTS01 309307CN7 SHICT18 00000312257CN9 503215PCT4 00000293010CN5 503DRCCT 00000296272CN8 518828CT 00000323860CN7 ALLIANCECT74 00000318314CN2 949949CT 00000310267CN0 715453CT1 00000317790CN4 612863LSC 00000321966CN4 732671LS16 00000338403CN9 850718JLS 00000336255CN5 702880CT 00000339629CN8 914681PRO 00000334464CN5 RADNETCT1483 00000297390CN7 518438LS16 00000362635CN5 615320CT 00000341886CN0 305285LS 00000314491CN2 252847CT3 00000321140CN6 773792PRO 00000331769CN0 775785CT16 00000320666CN1 972548LS16 00000313370CN9 434243UVICT1 00000311424CN6 770751QXI 00000297382CN4 206232CT1 00000299234CN5 RADNETCT1500 00000292531CN1 423272CT 00000296274CN4 574371CT16 00000288654CN7 703385LS16 00000277800CN9 415723SCT3 00000348034CN0 410337LS16 00000318730CN9 480237CT16 00000328358CN7 4147614XCT1 00000338570CN5 304526LSPRO 00000308842CN4 813870LS16 00000307026CN5 847437ACT4 00000332709CN5 940384MDCT 00000347365CN9 770736LCT 00000314952CN3 718918LS16 00000293011CN3 CT81441 00000313365CN9 706845WGLS 00000308983CN6 918494SFLS2 00000297426CN9 412777LS16 00000307024CN0 956969CT 00000324976CN0 770778CTP16 00000318876CN0 918683LS16 00000338401CN3 617355CT3 00000294503CN8 770718OCT1 00000347517CN5 509248VCT16 00000319953CN6 757886CT 00000351700CN0 RADNETCT1404 00000294766CN1 402481BWCT1 00000323330CN1 804864BRLS16 00000315054CN7 907729CTPRO 00000293499CN0 212860LS16 00000299763CN3 208467CTLS 00000299311CN1 910215MR16 00000320667CN9 281PERWCT 00000313649CN6 423586CT2 00000294504CN6 949760CT2 00000321162CN0 760775CT 00000298790CN7 ALLIANCECT67 00000300371CN2 573635SMCT2 00000299765CN8 703578LS16 00000331098CN4 425261CT 00000342628CN5 773967LS16 00000304113CN4 276666CT 00000293037CN8 631475LS16 00000295005CN3 785452SCT 00000296280CN1 805SVCT1 00000336852CN9 772335CT1 00000362634CN8 570522CT1 00000351636CN6 845334LS 00000316660CN0 402887CT16 00000308839CN0 309672MCT1B 00000349343CN4 281395LS16 00000320654CN7 352728FHVC1 00000295410CN5 919731CT16 00000333823CN3 330830LS16J 00000332736CN8 206731ERCT 00000308361CN5 972420LS16 00000329988CN0 912692LS3 00000346883CN2 281FCLPCT 00000349345CN9 605342RCMC 00000298345CN0 734240CT16 00000323050CN5 781340SCT4 00000332081CN9 401769WLS 00000310731CN5 904391CTLS 00000326112CN0 406293LCT 00000317788CN8 ALLIANCECT127 00000311417CN0 281274CT3 00000366432CN3 253944CT16 00000342587CN3 207777LS16 00000320668CN7 724537CTLS 00000301084CN0 914737CTLS 00000294344CN7 504873TL16 00000350494CN1 303695LS16 00000298360CN9 210292LSA 00000314950CN7 913541CT16 00000338127CN4 801773CT2 00000288959CN0 812471CT 00000285030CN3 843236CFCT 00000290655CN0 937534CT 00000843255YM1 916RASCCT 00000886944YM8 336433KV16 00000327821CN5 918294SCLS FMI25463001 412469CTH1 00000358633CN6 815338PRO 00000886897YM8 912355LS16 00000273706CN2 423698DLS 00000281948CN0 SHICT288 00000361749CN5 503513PCT16 00000289411CN1 812537LS16 00000279106CN9 302653LS16 00000267340CN8 513856CT 00000279054CN1 609652LS16 00000271998CN7 817551OPCT 00000176078HM4 989839RT16 FMI25463002 610270LSPRO 00000265944CN9 940328LS16 00000296243CN9 925813CTM 00000919623YM9 912748CT1 00000265771CN6 918224LSCT 00000278570CN7 478745CT 00000328341CN3 863687LS8ER 00000385174CN8 814624LS1 00000367539CN4 432685LS1 00000843223YM9 RADNETCT1503 FMI25463003 860444CTPRO 00000381259CN1 303340CTHP 00000285331CN5 850747GCCT 00000276921CN4 704362MQCT 00000376596CN3 775885PRO 00000269963CN5 903TSJCT16 00000379714CN9 208455CTLS 00000295008CN7 214345LS16 00000984695YM7 515247CT5 00000386311CN5 623207CT16 00000988390YM1 864225CT 00000984689YM0 9167345X 953828YM1 SHICT19 00000953839YM8 305592LS16 00000358180CN8 505848LCT 00000313368CN3 609584LS16 00000387780CN0 631MSKLS16 00000314494CN6 713566LCT2 00000350423CN0 904824FCT4 00000365567CN7 208524PETCT 00000382184CN0 252641HCT16 00000328883CN4 317745LSPRO 00001030388YM1 816691PCT2 00000360963CN3 858657RTCT 00000984696YM5 901726CT2 00000365453CN0 907459TVCT 00000317093CN3 940384LS16 00000766980YM7 205601BHCT 00000263412HM9 716UROCT 00000940961YM6 845887LS16 00000412581CN1 414541VCT1 00000300854CN7 605882CT 00000308734CN3 00000074379HM9 00000315227CN9 607734H16 00000313363CN4 765423LS16 00000308836CN6 214345LINUX16 00000330532CN3 561650CT1 00000298793CN1 847LS16CT1 00000882908YM7 919CHTMCT 00000345928CN6 718920LSRO FMI25463061 760242LS16 FMI25463062 DCOSDI200000094 FMI25463063 423224CT2 FMI25463064 435251CT1 FMI25463065 281258PERMB FMI25463066 DCOSDI400000077 FMI25463067 ALLIANCECT103 FMI25463068 ALLIANCEPCT85A FMI25463069 580323LSP FMI25463070 510889CT FMI25463071 215481LS16 FMI25463072 716839LS16 FMI25463073 617726PR12 FMI25463074 662538CT FMI25463075 916734CT1 FMI25463076 425261CT2 FMI25463077 DCOSDI100000086 FMI25463078 630325DLS FMI25463079 516520LS16 FMI25463080 812450PRO100 FMI25463081 SHAREDPET2 FMI25463082 717273CT1 FMI25463083 301496CTPET FMI25463084 972579L16A FMI25463085 608364ERCT FMI25463086 605622CT1 FMI25463087 716898CT FMI25463088 6036503T FMI25463089 720FCACT1 FMI25463090 662756CT FMI25463091 915EPDST1 FMI25463092 918786LS1 FMI25463093 435734CT2 FMI25463094 212639LS03 FMI25463095 706316CT1 FMI25463096 DCOSDI100000423 FMI25463097 765646LS16 FMI25463098 201330LS16 FMI25463099 715387CT2 FMI25463100 404329LS16 FMI25463101 DCOSDI200000112 FMI25463102 916784CT1 FMI25463103 DCOSDI000000343 FMI25463104 717633CT2 FMI25463105 313916LS16 FMI25463106 317582LSPRO FMI25463107 SMRDST6 FMI25463108 304255LS16 FMI25463109 DCOSDI300000210 FMI25463110 3411 FMI25463112 901729MSCT FMI25463113 209536CT1 FMI25463114 ALLIANCEPCT71P FMI25463115 303398CTLS16 FMI25463116 916734CT2 FMI25463117 724832CT FMI25463118 MISECT33L FMI25463119 734936CT1 FMI25463120 3155 FMI25463121 915670HLS2 FMI25463122 205759CTI2 FMI25463123 308537GH16 FMI25463124 870972LS16 FMI25463125 276679CTLS FMI25463126 317846LS FMI25463127 952924CT1 FMI25463128 206731CT1 FMI25463129 956350VRCT FMI25463130 847ARLS FMI25463131 610954CT16 FMI25463132 608263CT3 FMI25463137 919684B5A FMI25463138 919684C3A FMI25463139 319272LS16 FMI25463140 408757LS16 FMI25463141 630275LSER FMI25463142 760830CT FMI25463111 DCOSDI000000013
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) and to the countries of : ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CHINA, DENMARK, ESTONIA, FINLAND, FRANCE, GERMANY, HUNGRY, INDIA, INDONESIA, ISRAEL, ITALY, JAPAN, REPUBLIC OF KOREA, MEXICO, NORWAY, POLAND, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN and UNITED KINGDOM.
  • Product Description
    Lightspeed 16 CT
  • Manufacturer
    GE Healthcare

Manufacturer

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