Events

Switch Point Infinity 3 (Operating Room Management System) 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-2015-RN-01190-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2015-12-07
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01190-1
  • 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 become aware that for sources utilising s-video and composite inputs, phase alternating line (pal) signals appear with jagged edges on all diagonal lines resulting in poor video quality. the potential hazard associated with this failure is a pal signal used with s-video or composite input that produces an image that is not clear and free of artefacts.
  • 조치
    A Stryker Technical Service Representative will coordinate the update of affected devices. The update will correct the poor video quality as well as support for additional PAL resolution. This action has been closed-out on 29/08/2016.

Device

Switch Point Infinity 3 (Operating Room Management System)
  • 모델명 / 제조번호(시리얼번호)
    Switch Point Infinity 3 (Operating Room Management System)Catalogue Number: 0678001000All serial numbers affectedARTG Number: 232446
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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