Events

Innova 4100 / 4100 IQ 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 GE Medical Systems, 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
    52056
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0137-2010
  • 사례 시작날짜
    2009-04-16
  • 사례 출판 날짜
    2009-11-09
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-12-03
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82008
  • 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
    Cardiovascular Imaging System - Product Code IYO
  • 원인
    Potential pump failure associated with the coolix 4000 chiller of the innova single plane and biplane systems that may stop the chiller from working. if a chiller failure occurs, the user will be informed with a message on the n-room monitor stating that three minutes are left before the x-ray is inhibited. this could lead to a delay in treatment and possible additional x-ray exposure and contra.
  • 조치
    Consignees were sent on May 1, 2009 a GE Healthcare " Urgent Medical Device Correction" letter dated April 16, 2009. The letter was addressed to Hospital Administrator/ Risk Manger, Mangers of Radiology/ Cardiology, and Radiologists/ Cardiologists. The letter described the problem, Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information.

Device

Innova 4100 / 4100 IQ
  • 모델명 / 제조번호(시리얼번호)
    SYSTEM ID:  80158241 06014VAS01 06063VAS01 082406100018 0828160011 205759CL2  207662OR4100 215662INNOVA1  216844INNOVA  228809VASC  22925941V2  309672M4100 414649DVI 508383IN4100 509575YM4100  6012884100SUR  715369INN4100 718518CVL1  801268INNOVA 812825INNOVA1 843789SP1  865373SP 865541CCL5  904BSSP  910907WAVAS1  9408984100 A56364110 BG4037XR01 HC1819XR09 HC2001XR02 M2030711  NO1017VA03 NO1064VA04 RU2526VA01 XF0160
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA, ARGENTINA, BELGIUM, BRAZIL, BULGARIA, CHINA, CROATIA, EGYPT, FRANCE, GERMANY, HONG KONG, HUNGARY, INDIA, ITALY, JAPAN, REPUBLIC OF KOREA, LATVIA, LIBYA, MEXICO, NORWAY, POLAND, RUSSIA, SINGAPORE, SPAIN, SWEDEN, TAIWAN, TURKEY, UNITED KINGDOM, ROMANIA, ISRAEL, UKRAINE, YEMEN, BELARUS, and AUSTRALIA.
  • 제품 설명
    GE Healthcare, GE Innova 4100 / 4100 IQ. , ( The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector)
  • Manufacturer
    GE Medical Systems, LLC

Manufacturer

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