Events

Radiometer TCM5FLEX/BASICAll 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-2018-RN-00297-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2018-04-13
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00297-1
  • 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 that the wi-fi hardware incorporated in the tcm5 monitor is not compliant with respect to the requirements for radiated emission (radio equipment directive 2014/53/eu).Australian customers do not currently utilise the wi-fi option on these devices.
  • 조치
    Radiometer is advising that they will be contacting affected users to arrange for the software to be upgraded on TCM5 to V1.2.0 which will disable the Wi-Fi hardware. Customers have been supplied an updated IFU which removes reference to Wi-Fi as part of the correction undertaken for RC-2018-RN-00299-1

Device

Radiometer TCM5FLEX/BASICAll
  • 모델명 / 제조번호(시리얼번호)
    Radiometer TCM5FLEX/BASICAll Serial NumbersARTG Number:140333(Radiometer Pacific - Transcutaneous blood gas monitor)
  • Manufacturer
    Radiometer Pacific Pty Ltd

Manufacturer

Radiometer Pacific Pty Ltd