Events

Radiometer ABL90Flex analyser 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Radiometer Medical ApS 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
    17922
  • 사례 시작날짜
    2014-12-24
  • 사례 국가
    New Zealand
  • 사례 출처
    NZMMDSA
  • 사례 출처 URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • 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: Radiometer Pacific, Unit 3, 33 Spartan Road, Takanini 2105
  • 원인
    Manufacturer has become aware of a potential significant clinical issue with patient results if the inlet is left open after aspiration of the patient sample for more than 30 seconds., note that if the inlet is accidentally left open after processing a patient sample the abl90 analyser sounds a warning bell, places a warning message on the screen and also initiates a voice message continuously repeating "please close the inlet"., the problem can occur after the following sequence of actions:, 1.The operator aspirates patient sample a and forgets to close the inlet, 2.The inlet is left open for more than 30 seconds before it is closed, 3.An operator aspirates patient sample b, in this case the results for patient sample b are affected by this issue.
  • 조치
    Instructions for use to be updated

Device

Radiometer ABL90Flex analyser

Manufacturer

Radiometer Medical ApS