Events

Panther and Panther Fusion Systems with 19-in monitor 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Hologic 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-00065-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2018-01-18
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00065-1
  • 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
    Hologic has been made aware that the touch screen monitor provided with certain panther and panther fusion systems has the potential for the glass panel to separate due to inadequate adhesion between the glass panel and the monitor. hologic has received 2 complaints where the glass panel separated from the panther monitor. to date, there have been no reports of injuries associated with this defect; however there is a potential risk that the glass panel may fall and injure an operator.
  • 조치
    Hologic will contact affected customers to arrange for an interim solution to secure the glass panel to be installed. Subsequently, a replacement monitor with this issue corrected will be installed once made available.

Device

Panther and Panther Fusion Systems with 19-in monitor
  • 모델명 / 제조번호(시리얼번호)
    Panther and Panther Fusion Systems with 19-in monitorProduct code: 902615Serial Nos: 2090002307 to 2090002532Manufactured between April 2017 and Nov 2017ARTG Number: 260039 (Gen-Probe Australia Pty Ltd - Instrument/analyser IVDs)
  • Manufacturer
    Hologic Australia Pty Ltd

Manufacturer

Hologic Australia Pty Ltd