Events

Inflation bulbs used with Safescope Sigmoidoscopes 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Med-Chem Surgical 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-2013-RN-01237-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2013-12-09
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01237-1
  • 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
    Med chem is recalling affected bulbs following reports of inflation bulbs not compressing. after physical inspections of the fault by both logikal health and its supplier, it has been determined that this fault is due to a misshaped component within the valve located on the tubing which extends from the bellows.
  • 조치
    Med Chem Surgical is requesting their customers to test any remaining product from the affected batch by applying slight pressure through the packaging. Any bulbs that fail to compress must be returned immediately.

Device

Inflation bulbs used with Safescope Sigmoidoscopes
  • 모델명 / 제조번호(시리얼번호)
    Inflation bulbs used with Safescope SigmoidoscopesProduct Code: SCU-SS220Batch Number: 061326ARTG Number: 165977
  • Manufacturer
    Med-Chem Surgical Pty Ltd

Manufacturer

Med-Chem Surgical Pty Ltd
  • Source
    DHTGA