Events

TDL6000MC Disposable Diathermy - Spatula tip with handle (Electrosurgical electrode) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Life Healthcare 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-01073-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-10-16
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01073-1
  • 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 recall is due to the two pieces of insulation on the handle not overlapping sufficiently, allowing the diathermy pen to spark through the insulation join when used with high voltage.This recall action was carried out prior to approval of the recall communication by the tga.
  • 조치
    Life Healthcare has removed the affected stock from the customers. The manufacturer has redesigned the insulation to a one piece construction to remove the failure mode.

Device

TDL6000MC Disposable Diathermy - Spatula tip with handle (Electrosurgical electrode)
  • 모델명 / 제조번호(시리얼번호)
    TDL6000MC Disposable Diathermy - Spatula tip with handle (Electrosurgical electrode)Lot Number: 1219857ARTG Number: 198434
  • Manufacturer
    Life Healthcare Pty Ltd

Manufacturer

Life Healthcare Pty Ltd