HEATER-COOLER UNIT HCU 40 의 리콜

Health Canada (via FOI)에 따르면, 해당 리콜 는 Canada 에서 MAQUET-DYNAMED INC. 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
    35779
  • 사례 위험등급
    II
  • 사례 시작날짜
    2015-07-01
  • 사례 국가
  • 사례 출처
    HC
  • 비고 / 경고
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • 데이터 추가 비고
  • 원인
    Maquet cardiopulmonary recently detected a leak in the water circuit of an hcu 40 during the final quality inspection. the investigation revealed that the leakage was caused by a damaged sealant in the water circuit. the damage occurred during device assembly and it cannot be ruled out with absolute certainty that hcu 40s in the field equipped with the same type of sealant could exhibit this failure too. the hcu 40 with the serial number 90440265 could potentially exhibit a leak in the water circuit. in case of water leakage a short circuit of an electrical component and device shut down are the potential consequences.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: 70105.4054 (200-240V) (Lot serial: 90440265)
  • 제품 설명
    HEATER COOLER UNIT HCU 40
  • Manufacturer

Manufacturer

  • 제조사 주소
    MISSISSAUGA
  • 제조사 모회사 (2017)
  • Source
    HC