Events

MAQUET VOLISTA central handle on StanOP, TRIPOD and ACCESS Cupolas 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Getinge 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-2018-RN-00045-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2018-01-16
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00045-1
  • 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
    Getinge has received complaints indicating that the central handle holder detaches easily from the cupola during use. we determined that the root cause of this malfunction is excessive tightening of the screws during mounting of the handle holder, resulting in the rivets loosening and detaching from the central handle holder ring.During manipulation, the handle holder may completely detach from the light head, if all three rivets loosen simultaneously. in this case, although the handle remains in the user’s hand, small quantities of particles may be generated from the plastic holder ring.
  • 조치
    Getinge will be in contact with affected users to arrange for a service technician to replace existing central holder rings.

Device

MAQUET VOLISTA central handle on StanOP, TRIPOD and ACCESS Cupolas
  • 모델명 / 제조번호(시리얼번호)
    MAQUET VOLISTA central handle on StanOP, TRIPOD and ACCESS Cupolas Part Numbers: ARD568811950, ARD568811960, ARD568811961, ARD568811962, ARD568812910, ARD568812950, ARD568812960, ARD5688112962, ARD568821913,Serial Numbers (up to, for the above part numbers respectively): 50000, 500063, 500003, 500030, 500004, 50000, 500046, 500007, 500001ARTG Number: 162037 (Getinge Australia Pty Ltd - Light, surgical)
  • Manufacturer
    Getinge Australia Pty Ltd

Manufacturer

Getinge Australia Pty Ltd