Events

E.CAM or Symbia E System: Rear Casters of the Collimator Cart 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Siemens 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-00855-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-08-01
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00855-1
  • 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
    The rear casters of the collimator cart may become loose and under certain circumstances result in the cart tipping towards the operator. this problem occurs when two conditions are present: 1. the caster has insufficient clamping force and 2. the affected caster passes over a low spot in the floor. if both conditions exist, it is possible the caster will dislodge from the bottom of the cart, allowing the cart to tip backwards toward the operator.
  • 조치
    End users are advised that they can continue to use your system while waiting for the field correction to be scheduled and performed. However, if you suspect a caster is loose, as indicated by shaking while the cart is in motion, discontinue use of the collimator cart and notify your local Service representative. A retention bracket will be installed on all affected devices to correct the problem. This action has been closed-out on 24/05/2016.

Device

E.CAM or Symbia E System: Rear Casters of the Collimator Cart
  • 모델명 / 제조번호(시리얼번호)
    E.CAM or Symbia E System: Rear Casters of the Collimator CartCatalogue numbers: Collimator Carts 7760908, 7760882ARTG number: 186317
  • Manufacturer
    Siemens Ltd

Manufacturer

Siemens Ltd