Events

Device Recall GE Healthcare Advantx, Innova2000, Innova3100, Innova4100, Innova2100IQ, 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
    64178
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0947-2013
  • 사례 시작날짜
    2013-01-21
  • 사례 출판 날짜
    2013-03-13
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-01-16
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115500
  • 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
    Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
  • 원인
    A locking nut might loosen out of the overhead video monitor suspension yoke affecting advantx, innova 2000, innova 2100iq, innova 3100, innova 3100iq, innova 4100, and innova 4100iq cardiovascular x-ray imaging systems.
  • 조치
    GE Healthcare sent "URGENT MEDICAL DEVICE CORRECTION" letters dated January 18, 2013 and February 11, 2013 to all affected customers. The letters were addressed to Hospital Administrators / Risk Managers, Mangers of Radiology / Cardiology and Radiologists / Cardiologists. The letters described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. The second letter dated February 11, 2013 was sent out to consignees which incorporated an additional model number (2270677-2) which was initially missed. Contact the firm 800-437-1171 for questions regarding these letters.

Device

Device Recall GE Healthcare Advantx, Innova2000, Innova3100, Innova4100, Innova2100IQ,
  • 모델명 / 제조번호(시리얼번호)
    INNOVA 41001Q 00000000609MC8 00000000605MC6 00000000535MC5 00000000225MC3 00000000226MC1 00000000463MC0 00000000223MC8 00000000377MC2 00000000816MC9 00000000841MC7 00000000469MC7 00000000228MC7 00000000830MC0 00000001258MC3 00000000937MC3 00000000485MC3 00000000376MC4 00000000807MC8 00000001078MC5 00000000821MC9 00000000125MC5 00000000123MC0  INNOVA 4100  00000000207MC1 00000000823MC5 00000000814MC4 00000000468MC9 00000000484MC6 00000000465MC5 00000000462MC2 00000000229MC5 00000000606MC4 00000000553MC8 00000000669MC2 00000000212MC1 00000000477MC0 00000000667MC6  INNOVA 31001Q 00000000647MC8 00000000723MC7 00000000620MC5  INNOVA 3100 00000001211MC2 00000000765MC8  INNOVA 21001Q 00000000693MC2 00000000663MC5 00000000661MC9 00000001336MC7 00000001367MC2  INNOVA 2000 00000000099MC2 00000000109MC9 00000000126MC3 00000000128MC9 00000000140MC4 00000000152MC9 00000000161MC0 00000000164MC4 00000000166MC9 00000000169MC3 00000000171MC9 00000000173MC5 00000000175MC0 00000000176MC8 00000000177MC6 00000000178MC4 00000000179MC2 00000000180MC0 00000000199MC0 00000000201MC4 00000000202MC2 00000000320MC2 00000000323MC6 00000000324MC4 00000000357MC4 00000000358MC2 00000000367MC3 00000000374MC9 00000000375MC6 00000000410MC1 00000000423MC4 00000000429MC1 00000000499MC4 00000000501MC7 00000000502MC5 00000000504MC1 00000000513MC2 00000000517MC3 00000000163MC6 00000000124MC8 00000000151MC1 00000000153MC7 00000000154MC5 00000000165MC1 00000000366MC5 00000000430MC9 00000000431MC7 00000000459MC8 00000000500MC9 00000000514MC0 00000000127MC1 00000000460MC6 00000000097MC6 00000000426MC7 00000000108MC1 00000000447MC3 00000000168MC5 00000000085MC1 00000000098MC4 00000000107MC3 00000000448MC1 00000000449MC9 00000125283M02 00000000701MC3 00000000655MC1 00000000691MC6 00000000752MC6 00000000646MC0 00000000537MC1 00000000538MC9 00000000482MC0 00000000578MC5 00000000657MC7 00000000539MC7 00000000486MC1 00000000540MC5 00000000607MC2 00000000809MC4 00000000480MC4 00000000744MC3 00000000692MC4 00000000621MC3 00000000622MC1 00000000645MC2 00000000751MC8 00000000736MC9 00000000737MC7 00000000838MC3 00000000644MC5 00000000654MC4 00000000614MC8 00000000615MC5 00000001171MC8 00000001077MC7 00000001079MC3 00000000603MC1 00000000721MC1 00000000575MC1 00000000134MC7 00000001212MC0 00000000694MC0 00000000689MC0 00000000231MC1 00000000579MC3 00000000901MC9 00000000704MC7 00000000643MC7 00000000466MC3 00000000518MC1 00000000664MC3 00000000227MC9 00000000221MC2 00000000519MC9 00000000733MC6 00000000487MC9 00000000612MC2 00000000488MC7 00000000822MC7 00000000817MC7 00000001173MC4 00000000653MC6 00000000580MC1 00000000665MC0 00000000839MC1 00000000833MC4 00000000616MC3 00000000648MC6 00000000521MC5 00000000768MC2 00000000618MC9 00000000481MC2 00000000551MC2 00000000576MC9 00000000522MC3 00000000574MC4 00000000604MC9 00000000688MC2 00000000861MC5 00000000815MC1 00000000577MC7 00000000810MC2 00000000875MC5 00000000598MC3 00000000860MC7 00000000690MC8 00000000552MC0 00000000542MC1 00000000766MC6 00000000734MC4 00000000844MC1 00000000872MC2 00000000840MC9 00000000877MC1 00000000162MC8 00000000593MC4 00000000583MC5  ADVANTX 00000000290MC7 00000000726MC0 00000000546MC2 00000128246M06 00000000697MC3 00000000378MC0 00000000183MC4 00000000209MC7 00000000119MC8 00000000554MC6 00000000586MC8 00000000117MC2 00000000555MC3 00000000698MC1 00000000120MC6 00000000118MC0 00000000116MC4 00000000291MC5 00000000703MC9 00000000608MC0 00000000750MC0 00000000658MC5 00000000939MC9 00000000987MC8 00000000940MC7 00000001062MC9 00000000705MC4 00000000902MC7 00000000812MC8 00000000903MC5 00000000832MC6 00000000990MC2 00000000873MC0 00000000649MC4 00000001382MC1 00000000876MC3 00000000842MC5 00000000874MC8 00000000843MC3 00000000989MC4 00000001080MC1 00000000859MC9 00000000819MC3 00000000711MC2 00000000679MC1 00000000135MC4 00000000677MC5 00000000696MC5 00000000219MC6 00000000145MC3 00000128106M02 00000000136MC2 00000000637MC9 0000000128124M 00000000592MC6 00000000638MC7 00000000635MC3 00000000509MC0 00000000150MC3 00000000130MC5 00000000198MC2 00000000149MC5 00000000191MC7 00000000732MC8 00000000695MC7 00000000557MC9 00000000591MC8 00000000101MC6 00000000681MC7 00000000122MC2 00000000220MC4 00000000214MC7 00000000121MC4 00000000731MC0 00000000906MC8 00000000678MC3 00000000729MC4 00000000684MC1 00000000683MC3 00000000636MC1 00000000685MC8 00000000686MC6 00000000730MC2 00000000927MC4 00000000929MC0 00000000926MC6 00000000954MC8 00000000928MC2 00000000160MC2 00000000215MC4 00000000147MC9 00000000137MC0 00000000146MC1 00000000143MC8 00000000148MC7
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-USA (nationwide) including the states of AL, AZ, CA, CO, CT, FL, GA, IL, IN, IA, KS, KY, ME, MD, MA, MN, MS,MO, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, UT , VA, WA, WV, WI and the countries of VENEZUELA, UNITED KINGDOM, TURKEY, THAILAND, TAIWAN, SPAIN, SAUDI ARABIA, RUSSIAN FEDERATION, PORTUGAL, POLAND, NORWAY, NIGERIA, NICARAGUA, MOROCCO, MALTA, LEBANON, KAZAKHSTAN, JAPAN, ITALY, INDONESIA, INDIA, HUNGARY, GREECE, FRANCE, EGYPT, CHINA, CANADA, BRAZIL, BELGIUM, and NEW ZEALAND.
  • 제품 설명
    GE Healthcare Advantx, Innova2000, Innova3100, Innova4100, Innova2100IQ, || Innova3100IQ, and Innova4100IQ equipped with Video Monitor || Suspension Cardiovascular X-ray imaging systems. Model numbers 2236709, 2353620 ,2223039-2, and 2270677-2.
  • Manufacturer
    GE Healthcare, LLC

Manufacturer

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