Events

Shape Arm Kit Left and Shape Arm Kit Right (Mounting/positioning system for flat panel monitors) 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-00361-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2014-03-25
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00361-1
  • 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 there is a remote possibility that the lock washer and screw that secures the monitor onto the shape arm may not be present. if the shape arm lock washer and screw are not present the monitor could separate and dislodge from the arm potentially resulting in injury.
  • 조치
    Stryker is inspecting all affected Shape Arms to determine if the lock washer and screw are missing. If missing a new lock washer and screw will be fitted.

Device

Shape Arm Kit Left and Shape Arm Kit Right (Mounting/positioning system for flat panel monitors)
  • 모델명 / 제조번호(시리얼번호)
    Shape Arm Kit Left and Shape Arm Kit Right (Mounting/positioning system for flat panel monitors)Shape Arm Kit LeftCatalogue Number: 0682000976 Serial Numbers: 080924DC001 through 120227DC025Shape Arm Kit RightCatalogue Number: 0682000977 Serial Numbers: 080909DB001 through 131021DB013ARTG Number: 118878
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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