Events

Scherbak Weights – 400 gr and 800 gr (used with Scherbak vaginal speculum) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Medical & Optical Instruments 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-00944-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-09-03
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00944-1
  • 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
    Medical & optical has been advised by kls martin 400gr and 800gr weights, placed in the market place for the scherbak vaginal speculum, fractures can occur in the laser welded seam between the holding hook and the weight involved.
  • 조치
    Medical & Optical is recalling the affected stock and a replacement of the affected weights will be provided free of charge. This action has been closed-out on 04/04/2017.

Device

Scherbak Weights – 400 gr and 800 gr (used with Scherbak vaginal speculum)
  • 모델명 / 제조번호(시리얼번호)
    Scherbak Weights – 400 gr and 800 gr (used with Scherbak vaginal speculum)Affected part numbers: Scherbak Weight, 400gr - Art. No. 32-302-10-01Scherbak Weight, 800gr - Art. No. 32-302-12-01Full set: Art. No. 32-302-00-01ARTG number: 177280
  • Manufacturer
    Medical & Optical Instruments Australia Pty Ltd

Manufacturer

Medical & Optical Instruments Australia Pty Ltd