Maquet Operating Table with Fixture 1002.65AO Manufactured in the period between 2009 and 2013 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Maquet 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-2016-RN-00984-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2016-07-22
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 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 fixture (1002.65ao) is designed as a connecting element for the support and positioning of the patient’s head on a maquet operating table immediately before, during and after surgical interventions and as for examination and treatment. the fixture is used to adapt a range of different head rest and horseshoe head rests with a central square mount. post market surveillance reported that the welded joint between the square mount and the first fixable swivel joint had broken. as a cantilever design, this joint must bear the highest load of all welded joints. it has been determined that the breakage had been caused by ineffective welding in addition to rough handling and multiple overloading. serious injury to the patient's cervical spine may occur if the weld seam breaks during a procedure. there have been no reports of injuries as a result of this issue.
  • 조치
    A Maquet service technician will be contacting customers to arrange an appointment to carry out replacement of all associated components. Until the replacement has been performed, users are advised that the device should be inspected for damage before every use. In this context, particular attention should be paid to the potential for cracks at the weld in the area illustrated in the customer letter. In case of doubt, customers are advised not to use the fixture. This action has been closed-out on 26/05/2017.

Device

  • 모델명 / 제조번호(시리얼번호)
    Maquet Operating Table with Fixture 1002.65AO Manufactured in the period between 2009 and 2013ARTG Number: 163023
  • Manufacturer

Manufacturer