Stryker Standard Video Cart and Vision Mounting Arm 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-2013-RN-00976-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-09-20
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 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
    If the tension screw present in the mounting yoke of the vision mounting arm is loose and the user applies excessive force during positioning, the user can push the monitor out of the yoke. this will cause the monitor to dislodge from the mounting arm and fall potentially impacting an operator or patient.
  • 조치
    Stryker is advising users that a new screw and washer will be installed on all affected units to ensure the monitor is securely fastened to the mounting yoke. It is expected that this will be completed by April 2014.

Device

  • 모델명 / 제조번호(시리얼번호)
    Stryker Standard Video Cart and Vision Mounting ArmCatalogue Numbers: 0240099011 (Video Cart), 0240099011I (Video Cart), 0240095200 (Mounting Arm) All lots affectedARTG Number: 106511
  • Manufacturer

Manufacturer

  • 제조사 모회사 (2017)
  • Source
    DHTGA