Events

Proteus XR/a X-ray Imaging Systems 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 GE Healthcare 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-01300-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-12-12
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01300-1
  • 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
    It was reported that both the steel cables in a proteus system wall stand failed and the bucky cabinet (68kg) fell to the floor. the unit was not in use, no patient or operator injury was reported. the proteus wall stand assembly associated with this event was identified as model 600-0301. the steel cable used with this wall stand is 603-3220. an investigation concluded that the root cause was fatigue of the braided rope.
  • 조치
    1. GE Healthcare will correct all affected systems by replacing the steel cables at no cost. A GE Healthcare service representative will contact customers to arrange for this correction. 2. To prevent occurrence of these issues in the future, the Service Procedures including the service interval for periodic cable maintenance and replacement is also being updated. The updated Service Procedure (2273022-100 Rev 31) will be available by 15th Jan 2015 at a website link that is to be provided in the Customer Letter. This ation has been closed-out on 11/08/2016.

Device

Proteus XR/a X-ray Imaging Systems
  • 모델명 / 제조번호(시리얼번호)
    Proteus XR/a X-ray Imaging SystemsModel Number: 600-0301 ARTG Number: 98099
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd