Events

Power-LOAD (Cot Fastener) 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-2018-RN-00296-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2018-04-09
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00296-1
  • 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
    After installation of the power-load, the floor plate attachment brackets (pn: 6390-101-108) which allow the power-load anchor to be secured to the power-load floor plate may be found to be broken after removing the anchor. the manufacturer has advised that broken floor plate attachment brackets will not result in unintended movement of the cot under normal conditions. the holding strength of the cot is reduced as a result of this issue which may result in a detached cot with fastener or a detached fastener component in the event of an emergency service vehicle accident. to date, there have been no reported injuries as a result of this issue.
  • 조치
    Stryker is advising that they will be replacing potentially affected parts on all Power-LOAD units manufactured within the suspected time frame. A Stryker Technician will contact users upon receipt of the Notification Response Form provided with the Customer Letter (issued to affected users) to co-ordinate the correction.

Device

Power-LOAD (Cot Fastener)
  • 모델명 / 제조번호(시리얼번호)
    Power-LOAD (Cot Fastener)Item Numbers: 6390000000, 6390BASIC, 6390SSPAUnits manufactured between Jan 1 2016 to Dec 31 2016All serial numbers beginning with “16” are within scope of this action ARTG Number: 275902
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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