Events

SERFAS 90° Energy Probe (90R Probe) (Electrosurgical system electrode) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Stryker 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-2015-RN-00574-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-06-29
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00574-1
  • 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
    Stryker has been made aware of a spike in the occurrence of tip breaks identified for the 90r probe. the investigation triggered by same confirmed the shape and location of the tip break in each case to be the same. in each event a small piece from the distal end of the alumina ceramic broke off. the geometry of this type of crack differs from those normally observed by serfas probes.
  • 조치
    Customers are asked to check any SERFAS 90° Energy Probe items in their possession and quarantine any affected units immediately . A Stryker Representative will coordinate an inspection of your affected items in quarantine. Any affected items will be removed by the Stryker Representative and a credit will be issued. This action has been closed-out on 08/08/2016.

Device

SERFAS 90° Energy Probe (90R Probe) (Electrosurgical system electrode)
  • 모델명 / 제조번호(시리얼번호)
    SERFAS 90° Energy Probe (90R Probe) (Electrosurgical system electrode)Item Number: 279-350-101Affected Lots: 13128AE2 to 14337AE2ARTG Number: 146512
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

Stryker Australia Pty Ltd
  • 제조사 모회사 (2017)
    Stryker
  • Source
    DHTGA