Events

Luminos dRF (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-00456-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2014-04-17
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00456-1
  • 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 rare environmental conditions (i.E., extremely dry air in combination with a highly isolated floor) electrostatic discharges (esd) >8 kv at the system control console may trigger an unintended movement of the system which may cause an emergency situation, danger to the patient (e.G., falling off the table, squeezing), to operating personnel or to the unit. to date, a sporadic occurrence of this system malfunction has been reported from two sites.
  • 조치
    Customers are advised to press one of the red emergency STOP buttons immediately in case of an unintended movement. The system needs to be restarted afterwards to be fully functional again. Siemens is preparing a modification of the Luminos dRF system control console that will resolve this potential malfunction. The field modification will be available from May 2014.

Device

Luminos dRF (Fluoroscopic diagnostic x-ray systems)
  • 모델명 / 제조번호(시리얼번호)
    Luminos dRF (Fluoroscopic diagnostic x-ray systems)Catalogue number: 10094200 ARTG Number: 102182
  • 의료기기 분류등급
    Radiology Devices
  • Manufacturer
    Siemens Ltd

Manufacturer

Siemens Ltd