Events

Blackmax, Micromax, Xmax Anspach Pneumatic Drill Systems / Hoses without a pressure relief valve (PRV) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Synthes 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-2013-RN-00451-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2013-05-20
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00451-1
  • 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
    The hand piece' s outer hose can rupture without warning if the air flow is blocked during use, this issue involves all drill system hose assemblies manufactured prior to a design change that became effective on may 13, 2009 incorporating a pressure relief valve.
  • 조치
    End users are requested to inspect their stock to determine if they have any pneumatic drill systems without a pressure release valve. All affected device are to be returned to DePuy Synthes for rework/modification.

Device

Blackmax, Micromax, Xmax Anspach Pneumatic Drill Systems / Hoses without a pressure relief valve ...
  • 모델명 / 제조번호(시리얼번호)
    Blackmax, Micromax, Xmax Anspach Pneumatic Drill Systems / Hoses without a pressure relief valve (PRV)ARTG Number: 141599
  • Manufacturer
    Synthes Australia Pty Ltd

Manufacturer

Synthes Australia Pty Ltd