Events

InTouch Critical Care Bed 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Stryker Australia 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-00727-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-07-04
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00727-1
  • 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
    Stryker has received complaints from the field regarding intouch beds, which allege that a caster has broken on the top of the caster stem where the brake rod inserts into the caster. these broken casters are identified when the intouch beds are hoisted or lifted from the floor during regular maintenance. if more than one caster on a unit is damaged, brake functions may be affected and result in reduced brake holding force. if only one caster on the bed is damaged, brake functionality continues to meet specifications.
  • 조치
    A Stryker representative will perform an onsite inspection to determine if casters are affected. If affected the casters will be replaced. End users are reminded to not use the electronic brake to slow or stop the bed while it is in motion.

Device

InTouch Critical Care Bed
  • 모델명 / 제조번호(시리얼번호)
    InTouch Critical Care Bed Item Number: 2156000000 All lots affectedARTG Number: 202755 (cancelled 21 March 2014)
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

Stryker Australia Pty Ltd
  • 제조사 모회사 (2017)
    Stryker
  • Source
    DHTGA