Events

Suction Adapter Type A (Gauge) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Xcel Medical Solutions 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-00929-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-09-16
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00929-1
  • 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 manufacturer has become aware that the affected connector may have a defective limit pin on the on-off lever, which would cause the pin to stick to the groove on the back of the on-off lever. this may result in the lever to break, resulting being unable to turn on or off the valve.This recall was undertaken prior to approval by the tga.
  • 조치
    Xcel Medical Solutions is requesting users to quaratine affected stock and return to Xcel Medical Solutions for replacement or full refund.

Device

Suction Adapter Type A (Gauge)
  • 모델명 / 제조번호(시리얼번호)
    Suction Adapter Type A (Gauge)Reference Number: X05101Lot Number: Z141203ARTG Number: 194212
  • Manufacturer
    Xcel Medical Solutions Pty Ltd

Manufacturer

Xcel Medical Solutions Pty Ltd
  • Source
    DHTGA