Events

Radiometer TCM5 Flex Monitor (non-invasive 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-01264-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-09-23
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01264-1
  • 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 of a potential risk that the tcm5 monitor may not be compliant with the waterproof specification, ipx2, which is required for a homecare environment. the problem is caused by incorrect assembly and may allow water to enter into the monitor, which may pose a risk of electrical shock for the user. there have been no reports of injuries as a result of this issue.
  • 조치
    Radiometer is advising users to stop use of the affected devices until they have been inspected and repaired where required by a Radiometer representative. A loan unit will be provided while the device is being repaired. This action has been closed-out on 17/05/2017.

Device

Radiometer TCM5 Flex Monitor (non-invasive blood gas monitor)
  • 모델명 / 제조번호(시리얼번호)
    Radiometer TCM5 Flex Monitor (non-invasive blood gas monitor)Serial Numbers: below 393-500R0030N009ARTG Number: 140333
  • Manufacturer
    Radiometer Pacific Pty Ltd

Manufacturer

Radiometer Pacific Pty Ltd