Events

Trumpf Table Top Spinal System (T3SYSTEM) Manufacturing Dates: March 2009 to November 2016 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Trumpf Med Aust 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-2018-RN-00316-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2018-04-20
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00316-1
  • 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
    Allen medical has become aware that the rail section clamps used to attach the leg support of the t3 trumpf table may fail during use, which could result in critical harm to the patient. the t3 trumpf table top rail section clamps, f-t3railsc, are designed and labelled for use with armboards only but were shipped to be used with the leg support. the instructions for use (d-720595-a3) incorrectly guides the user to connect the top rail section clamp to the leg support.Three complaints without any allegation of injury have been reported since introduction in september 2009.
  • 조치
    Trumpf are advising users to ensure that the T3 Trumpf Table Top Rail Section Clamps are used with armboards only. Users should inspect beds and remove any clamps currently in use with the Leg support. Allen Medical will be providing users with new Rail Section Clamps along with revised Instructions for Use. These are expected to be available by May 2018.

Device

Trumpf Table Top Spinal System (T3SYSTEM) Manufacturing Dates: March 2009 to November 2016
  • 모델명 / 제조번호(시리얼번호)
    Trumpf Table Top Spinal System (T3SYSTEM)Manufacturing Dates: March 2009 to November 2016ARTG Number: 252619(Trumpf Med Aust - Table, operation)
  • Manufacturer
    Trumpf Med Aust Pty Ltd

Manufacturer

Trumpf Med Aust Pty Ltd