Events

OEC Elite systemsDistributed between 27 October 2016 and 28 March 2017 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-2017-RN-00643-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-05-19
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00643-1
  • 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
    Ge healthcare surgery recently identified that product use labels on certain oec elite systems were missing or applied in the incorrect location on the device. the missing labels have the potential to result in users overlooking safe operating practices and exposing themselves or others to potential hazards that may lead to significant harm. to date, there have been no injuries reported because of this issue.
  • 조치
    Users are advised they may continue to use the OEC Elite system and to consult the Operator Manual regarding safe use of the system and precautions to be taken: - before initial use of the device - when transporting or moving the system - when connecting, or disconnecting external equipment/accessories - when locking, and unlocking brakes using the brake handle or pedal - when checking/contacting electrical connectors GE Healthcare will contact users to arrange for product correction.

Device

OEC Elite systemsDistributed between 27 October 2016 and 28 March 2017
  • 모델명 / 제조번호(시리얼번호)
    OEC Elite systemsDistributed between 27 October 2016 and 28 March 2017ARTG Number: 132698
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd