Events

Radiometer TCM5 transcutaneous blood gas monitor 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-2016-RN-01416-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2016-11-02
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01416-1
  • 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 part of the specifications stated in the tcm5 instructions for use (ifu) for professionals for tc sensor 92 is incorrect.The current ifu state incorrectly under “combined effects of linearity and hysteresis” the following:- at 33 % co2: better than 3 mmhg or 0.40 kpathe correct statement is:- at 33 % co2: better than 5 mmhg or 0.67 kpa.The above correction is not considered to be of clinical significance.
  • 조치
    Radiometer is currently updating the Instructions for use and will distribute the updated version to customers when available. In the interim, users are notified of the update through the customer letter. This action has been closed-out on 23/06/2017. This action has been closed-out on 23/06/2017.

Device

Radiometer TCM5 transcutaneous blood gas monitor
  • 모델명 / 제조번호(시리얼번호)
    Radiometer TCM5 transcutaneous blood gas monitorARTG Number:140333
  • Manufacturer
    Radiometer Pacific Pty Ltd

Manufacturer

Radiometer Pacific Pty Ltd