Events

Cios Alpha mobile C-arm 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-2015-RN-00399-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-05-13
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00399-1
  • 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
    Under certain circumstances the following user actions may cause the system to freeze. ·when images were transferred from the left monitor to the right monitor (function a to b) during image acquisition (i.E. radiation on) or shortly before starting image acquisition·when acquisition of image was started while storing of scenes initiated by pressing the store button was still in progress·when scene replay was initiated either automatically or by pressing the “play” button (especially when pressing the “play” button more than once) while the storing of those scenes was still in progress·when image acquisition was initiated again before automatic replay of the last scene started·when finalized cd/dvds were used to store additional data·when radiation summary reports with more than 190 entries were being exported·when system restart was initiated when the error message “system blocked. turn system off/on” (error codes 215/80 and/or 208/80) was displayed.
  • 조치
    Siemens has provided a workaround whilst a system modification is being developed which is expected for July 2015. This action has been closed-out on 11/08/2016.

Device

Cios Alpha mobile C-arm x-ray system
  • 모델명 / 제조번호(시리얼번호)
    Cios Alpha mobile C-arm x-ray systemCatalogue number: 10308191ARTG number: 102180
  • Manufacturer
    Siemens Ltd

Manufacturer

Siemens Ltd