Artis Q and Artis Q.zen Ceiling Systems (Fluoroscopic angiographic x-ray system)) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Siemens 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-2014-RN-01307-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-12-12
  • 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
    During regular product monitoring, wear on system cabling was identified. in particular, wear may occur at the cable outlet of the inner c-arm. this problem is not systematic, but occurs sporadically on individual systems throughout the lifetime of the system. suboptimal routing of the cable may result in increasing wear. without intervention to manage this wear, damage to cabling may result in limited functionality and, in the worst case, system failure where a procedure may need to be terminated.
  • 조치
    The existing cable routing at the C-arm will be modified to prevent cable damage. The following hardware modification will be implemented in the field : 1. A modified cable outlet to provide additional space for the cabling. 2. A modified plastic cover at the cable outlet providing optimal cable guidance in the area most at risk of wear All systems will be checked to determine if there is existing damage to cabling. Where damage is observed, the entire cable harness will be replaced. This action has been closed-out on 14/07/2016.

Device

  • 모델명 / 제조번호(시리얼번호)
    Artis Q and Artis Q.zen Ceiling Systems (Fluoroscopic angiographic x-ray system)) Serial Numbers: 109000 to 109091 (Artis Q), and 111000 to 111005 (Artis Q.zen)ARTG Number: 102177
  • Manufacturer

Manufacturer