Events

Radiometer ABL800 series blood gas analysers 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
    21056
  • 사례 시작날짜
    2017-04-06
  • 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
    On the abl800 series analyzers the sample type cord blood has been changed into the two sample types cord blood arterial and cord blood venous. this change took place with software version 3.1 mr5. an operator or clinician who is aware that the sample types that can be selected on abl800 series analyzer are cord blood arterial and cord blood venous may notice that a less specific sample type cord blood appears in the his/lis or middleware system., followup april 2017: the final solution to this issue is an upgrade of the abl800 software to software version 6.17 or higher. this new version ensures that cord blood arterial and cord blood venous are transmitted correctly to a his/lis or a middleware system.
  • 조치
    Manufacturer to issue advice regarding use

Device

Radiometer ABL800 series blood gas analysers
  • 모델명 / 제조번호(시리얼번호)
    Model: , Affected: All connected to HIS/LIS or middleware Data Management system
  • Manufacturer
    Radiometer Medical ApS

Manufacturer

Radiometer Medical ApS