Sorin Heater Cooler Systems 1T and 3T devices 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Sorin Group Deutschland GmbH 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
    18718
  • 사례 시작날짜
    2015-06-23
  • 사례 국가
  • 사례 출처
    NZMMDSA
  • 사례 출처 URL
  • 비고 / 경고
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • 데이터 추가 비고
    Recalling Organisation: Obex Medical Ltd, 303 Manukau Road, Epsom, AUCKLAND
  • 원인
    Sorin has become aware that the actual disinfection practices and the water maintenance that some users have been performing are not always conducted according to the instructions for use. without vigilant performance of the disinfection and maintenance procedures per the instructions for use, organisms can multiply in a heater cooler device and potentially form biofilm.
  • 조치
    Instructions for use to be updated

Device

  • 모델명 / 제조번호(시리얼번호)
    Model: , Affected: All serial numbers starting with 16SXxxxx are affected
  • Manufacturer

Manufacturer