Events

Device Recall Lightspeed 16 CT 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 GE Healthcare 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    71842
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2801-2015
  • 사례 시작날짜
    2015-07-17
  • 사례 출판 날짜
    2015-09-21
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-03-08
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139199
  • 비고 / 경고
    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.
  • 데이터 추가 비고
    System, x-ray, tomography, computed - Product Code JAK
  • 원인
    Potential for expulsion of the power supply on lightspeed ct scanner or discovery st pet ct or discovery ls pet ct scanner.
  • 조치
    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
  • 모델명 / 제조번호(시리얼번호)
    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 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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 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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 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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
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    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.
  • 제품 설명
    Lightspeed 16 CT
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare
  • 제조사 주소
    GE Healthcare, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • 제조사 모회사 (2017)
    General Electric Company
  • Source
    USFDA