Events

Ceiling system for Artis Zee System (Fluoroscopic angiographic digital 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-2013-RN-01163-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2013-11-20
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01163-1
  • 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
    Cables in the cable harness of the ceiling carriage may have received wear and tear or damage resulting in loss of system movement or loss of complete functionality. siemens technical specialists have advised that this issue could result in a limited or total loss of functionality with regards to the system movement. the cable damage caused by this issue would only affect system movement, not the imaging. however, as this type of system may be used during procedures for the placement of catheters, pacemakers, transcatheter aortic valve implantations etc. the loss of system movement may limit the available imaging during this type of procedure.
  • 조치
    Siemens is inspecting all potentially affected cables and installing an additional cable guide system to prevent wear if necessary.

Device

Ceiling system for Artis Zee System (Fluoroscopic angiographic digital x-ray system)
  • 모델명 / 제조번호(시리얼번호)
    Ceiling system for Artis Zee System (Fluoroscopic angiographic digital x-ray system)Catalogue Number: 10094137Serial Numbers: 146367, 146674, 146718, 146880, 146910, 146926, 146967, 147054, 147092, 147095, 147101, 147102, 147518All systems equipped with a ceiling stand with serial numbers from 10701 to 11557ARTG Number: 120177
  • 의료기기 분류등급
    Radiology Devices
  • Manufacturer
    Siemens Ltd

Manufacturer

Siemens Ltd