GE Healthcare, Discovery MR450, Discovery MR750, Optima MR450w, Optima MR 450w GEM, Discovery MR750w 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 GE Healthcare, LLC 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
    67913
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1480-2014
  • 사례 시작날짜
    2014-04-02
  • 사례 출판 날짜
    2014-04-21
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2015-04-08
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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, nuclear magnetic resonance imaging - Product Code LNH
  • 원인
    Potential safety issue with gradient coil electromechanical connections associated with ge mr products. gradient coil electromechanical connections may loosen causing an increase in resistance. the increased resistance can lead to increasing heat during scanning which, in turn, can cause material in the rear endbell enclosure to overheat, generate smoke in the scan room, and cause some localize.
  • 조치
    Consignees were sent on 4/2/2014 a GE Healthcare "Urgent Medical Device Correction" letter dated April 2, 2014. The letter was addressed to Hospital Administrators / Risk Mangers, Radiology Department Mangers and Radiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product correction and Contact Information (Fore questions, contact your local service representative ).

Device

  • 모델명 / 제조번호(시리얼번호)
    .FMI 60865 (DV Family Gradient Connections)  Mfg Lot or Serial # SystemID 00001250FMM026 919684DMPMR1 00000301309MR1 6628 00000000HM0426 6947 00000305379MR0 7462 00001018XF503B 205592750 00001227FMM00T 201445750W 00000297006MR9 202476MR1 00000296307MR2 202476MR2 00000297727MR0 202476MR3 00000300562MR6 202476MR4 00000000UA0153 202966MR3TW 00000305414MR5 203739MR450W 00000301842MR1 203863MR450W 00001203FMMOUJ 205750MR5 00000298836MR8 205838MR4 00000298249MR4 205949MR450W 00000301841MR3 206292SR450W 00000000UA0026 206292SR750W 00000293338MR0 206CH750MR 00000295024MR4 207945MR750 00001250FMM033 207OA450WMR 00000305461MR6 208882MR450W 00000299644MR5 209225VC450 00001026XF5173 209225VC750 00001105XF502C 209SJMR 00000000UA0143 210617HUBMR 00000300706MR9 210MSMTMR 00000000UA0052 21277MR1 00000301045MR1 212989MR1 00000305990MR4 212GE450W 00000301820MR7 214266PCBCMR1 00000302494MR0 214302PDWMR1 00000300930MR5 214590MWMRE3 00001250FMM02W 214645UT3TMR1 00000030251MR2 215ARIA450W 00000304079MR7 217223BHMR 00000303322MR2 217258SBMR1 00000294098MR9 217383CMR5 00000291464MR6 217528MR1 00000000HM0640 217532DVMR 00000299560MR3 217732LMR 00000292843MR0 217788MR3 00001250FMM02E 217876DMH3T 00000307113MR1 217876FMR 00000303450MR1 218828MR 00000000UA0203 225763MR2 00000306130MR6 229228450W 00000123FMM0K4 239VA450MR 00000296369MR2 240215MR 00000302363MR7 240313MR 00000301471MR9 240683MR 00000292634MR3 2486613TMR 00000298535MR6 252436MPMR 00000299171MR9 252482MR450 00001250FMM02T 252NDMR450W 00000296070MR6 253596GHTMR 00001307FMM05K 256881MR1 00001301FMM04T 256HHMR2 00000296840MR2 256HICMR2 00000302944MR4 256ODCMR1 00000303639MR9 260426VAMR 00000301255MR6 260920MR 00000302633MR3 262656MR1 00000301867MR8 262687MR1 00000308096MR7 262785mr1 00000295802MR3 269DVMR 00000000UA0138 270798MR2 00000294057MR5 281274MR1 00000000UA0028 281274MR2 00000290050MR4 281276MR750 00000298727MR9 281348450WMR 00000296429MR4 281364MR2 00001001BD6325 281477MR2 00000304177MR9 301295MR3T2 00000295215MR8 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  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-US (nationwide) except the states of ND and RI, including DC, GU, PR, and the countries of ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA,AZERBAIJAN, BAHRAIN, BELARUS, BELGIUM, BRAZIL, CANADA, CAYMAN ISLANDS, CHILE, CHINA, CZECH REPUBLIC, DENMARK, EGYPT, FINLAND, FRANCE, FRENCH POLYNESIA, GERMANY, GREECE, HONG KONG, HUNGARY, INDIA,INDONESIA, IRELAND, ISRAEL, ITALY, JAPAN, KAZAKHSTAN, KOREA, KUWAIT, LEBANON, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, NORWAY, OMAN, POLAND, PUERTO RICO, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TUNISIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, UZBEKISTAN, VENEZUELA.
  • 제품 설명
    GE Healthcare, Discovery MR450, Discovery MR750, Optima MR450w, Optima MR 450w GEM, Discovery MR750w, and Discovery MR750w GEM products. Magnetic Resonance Diagnostic Device.
  • Manufacturer

Manufacturer

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