Luminos dRF and Luminos dRF Max systems(Fluoroscopic diagnostic x-ray systems) 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-00923-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-08-21
  • 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
    There is the potential for malfunction when exposing the table side control panel of the luminos drf / luminos drf max system to fluids. if the panel is infiltrated by fluids, malfunctions may occur when buttons on the control panel are pressed, in the worst case the patient may slip off the table if the table is activated erroneously. in a very unlikely scenario, fluid may cause a permanent short circuit within the control panel and automatically disable the affected button(s) with the start-up of the system. in this case the system remains functional as it can be operated via the remote control panel.
  • 조치
    Siemens is advising end users to avoid extensive exposure of fluids to the table side control panel when using the system. When cleaning the system, please make sure that you do not apply excessive fluids: i.e., only use damp towels, in accordance with the product manual. The remote control panel is not affected by any malfunction of the table side control panel and can reliably be used at any time. Siemens is currently working on a permanent solution to eliminate the risk of fluid infiltration. This action has been closed-out on 24/05/206.

Device

  • 모델명 / 제조번호(시리얼번호)
    Luminos dRF and Luminos dRF Max systems(Fluoroscopic diagnostic x-ray systems)Luminos dRF systems with software version VD10Catalogue Number: 10094200Luminos dRF Max systems with software version VE10Catalogue Number: 10762471ARTG Number: 102182
  • Manufacturer

Manufacturer