Events

Device Recall Innova 4100/4100IQ with InnovaIQ Table Option 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
    55552
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1923-2010
  • 사례 시작날짜
    2010-06-03
  • 사례 출판 날짜
    2010-06-29
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-09-28
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91113
  • 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 - Product Code MQB
  • 원인
    Ge healthcare has become aware of a potential loss of gantry and table motions affecting innova 2100iq, 3100, 3100iq, 4100 and 4100iq systems with innovaiq table that may impact patient safety.
  • 조치
    Consignees were sent on 6/3/10 a GE Healthcare "Urgent Medical device Correction" letter dated May 12, 2010. The letter was addressed to Hospital Administrators/ Risk Mangers, Managers of Radiology/Cardiology and Radiologists/ Cardiologists. The letter included the Safety Issue, Affected Product details, Safety Instructions, Product Correction and Contact Information. Customers are to contact a service representative immediately if they notice any cable damage.

Device

Device Recall Innova 4100/4100IQ with InnovaIQ Table Option
  • 모델명 / 제조번호(시리얼번호)
    00000008C20212 00000453925BU0 00000000200WV6 00000000154WV5 00000000077WV8 00000000150WV3 00000000127WV1 00000000084WV4 00000000040WV6 00000000046WV3 00000000148WV7 00000000051WV3 00000000169WV3 00000000133WV9 00000000145WV3 00000000080WV2 00000000034WV9 00000000088WV5 00000000147WV9 00000000037WV2 00000000035WV6 00000000052WV1 00000000129WV7 00000000141WV2 00000000113WV1 00000000055WV4 00000000189WV1 00000000131WV3 00000000190WV9 00000000022WV4 00000000087WV7 00000000163WV6 00000000230WV3 00000000134WV7 00000000058WV8 00000000044WV8 00000000043WVO 00000000144WV6 00000000140WV4 00000000164WV4 00000000152WV9 00000000039WV8 00000000136WV2 00000000025WV7 00000000139WV6 00000000199WV0 00000000041WV4 00000000024WV09 00000000054WV7 0000000165WV10 00000000198WV2 0000000191WV70 00000000156WV0 00000000157WV8 00000000211WV3 00000000132WV1 00000000026WV5 00000000158WV6 00000000205WV5 00000000143WV8 00000000049WV7 00000000168WV5 00000000078WV6 00000000240WV2 00000000210WV5 00000000160WV2 00000000085WV1 00000000036WV4, and  00000000038WV0.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA, including states of AL, AZ, CA, CO, FL, GA, IL, IN, KY, MA, MI, MS, MO, MT, NE, NJ, NY, NC, OH, OR, PA, TN, TX, VT, WA, WV, and WI and countries of UNITED KINGDOM, SWEDEN, REPUBLIC OF KOREA, NORWAY, NEW ZEALAND, ITALY, ISRAEL, IRELAND, INDIA, HONG KONG, GERMANY, FRANCE, FINLAND, CZECH REPUBLIC, and AUSTRALIA.
  • 제품 설명
    Innova 4100/4100IQ system with InnovaIQ Table Option || Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, || rotational imaging procedures.
  • 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