ABL90Flex battery module used with Radiometer ABL90FLEX blood gas analyser (Optional battery). An in vitro diagnostic medical device (IVD) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Radiometer Pacific Pty Ltd 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
    RC-2015-RN-00805-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-08-27
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • 데이터 추가 비고
  • 원인
    Radiometer has recently become aware of a potential issue where a battery module had overheated caused by the continued charging of a collapsed battery cell. they have identified that worn battery modules with limited or no capacity manufactured in production runs below 910-311p0009nxxx are prone to cell collapses.
  • 조치
    Radiometer is advising users that battery modules below 910-311P0009Nxxx will be replaced with a newly designed battery module. Radiometer is advising users with battery modules 910-311P0009Nxxx and above will be required to undertake 12 monthly checks of the capacity of the battery modules. This action has been closed-out on 11/08/2016.

Device

  • 모델명 / 제조번호(시리얼번호)
    ABL90Flex battery module used with Radiometer ABL90FLEX blood gas analyser (Optional battery). An in vitro diagnostic medical device (IVD)Battery modules: below 910-311P0009NxxxAll serial numbers affectedARTG Number: 228382
  • Manufacturer

Manufacturer