Events

MEDRAD Continuum Infusion PumpSystems ditributed prior to March 2008 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Imaxeon 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-2014-RN-00426-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2014-04-11
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00426-1
  • 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
    Bayer healthcare is recalling brackets used to mount the continuum pump on the iv pole distributed with non-wireless versions of medrad continuum mr infusion systems prior to march 2008. these brackets are being recalled because of a potential safety risk in the mri environment associated with locking pins which may become damaged and not restrain the pump from being attracted to the mri magnet.
  • 조치
    Imaxeon is requesting their customers to inspect their bracket immediately. If a bracket has a damaged pin end users are advised to cease use immediately and remove from the MR scan room. Undamaged brackets should be inspected every time a Continuum Pump is installed or removed until a replacemnt bracket is supplied.

Device

MEDRAD Continuum Infusion PumpSystems ditributed prior to March 2008

Manufacturer

Imaxeon Pty Ltd
  • 제조사 모회사 (2017)
    Bayer AG
  • Source
    DHTGA