Events

Device Recall Critikon 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 GE Medical Systems Information Technologies 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
    26278
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0014-04
  • 사례 시작날짜
    2000-11-16
  • 사례 출판 날짜
    2003-10-15
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-05-03
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27423
  • 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
  • 원인
    Instructions for use contained incorrect sensor reference.
  • 조치
    A recall notification letter with the correct 'Instructions for Use' attached, was mailed certified return receipt requested to accounts on 11/16/2000. Follow-up contact was made by mail or telephone until 100% response was completed. No return of product was requested but rather users were provided with the correct instructions for use.

Device

Device Recall Critikon
  • 모델명 / 제조번호(시리얼번호)
    Lot numbers 008 and 005
  • 유통
    Product was distributed to 69 domestic hospitals nationwide including four military accounts. Also product was distributed 6 accounts in Canada, one in Thailand, one in Chile, one in Japan and one in singapore.
  • 제품 설명
    Critikon brand Omni-Sat Neonatal, Semi-Disposable Sensor, P/N 009130
  • Manufacturer
    GE Medical Systems Information Technologies

Manufacturer

GE Medical Systems Information Technologies
  • 제조사 주소
    GE Medical Systems Information Technologies, 4502 Woodland Corporate Blvd., Tampa FL 33614
  • Source
    USFDA