Events

Radiometer TCM5 FLEX/ BASIC Transcutaneous 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-2018-RN-00299-1
  • 사례 위험등급
    Class I
  • 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-00299-1
  • 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 previously informed users that they had received reports that instruments sensitive to electromagnetic interference may be affected by tcm5 measurements (tga ref: rc-2018-rn-00081-1 and rc-2017-rn-01327-1).Radiometer has released the revised version of the instructions for use which includes a separate paragraph in the introduction section under “electromagnetic interference”. this amendment is included from the tcm5 instructions for use, 996-436, version 201801f, pages 5 and 6. the updated ifu mirror the actions for users identified in rc-2018-rn-00081-1.
  • 조치
    Radiometer is advising users to discard previous revisions of the Instructions for Use and replace these with the new versions. Radiometer is working on a solution, which involves a hardware redesign of the TCM5 monitoring system, for this issue. Users will be contacted by their Radiometer representative when the final solution is available.

Device

Radiometer TCM5 FLEX/ BASIC Transcutaneous Monitor
  • 모델명 / 제조번호(시리얼번호)
    Radiometer TCM5 FLEX/ BASIC Transcutaneous MonitorAll Serial NumbersARTG Number: 140333(Radiometer Pacific - Transcutaneous blood gas monitor)
  • Manufacturer
    Radiometer Pacific Pty Ltd

Manufacturer

Radiometer Pacific Pty Ltd