Events

Allura Xper R8.2.0 (Fluoroscopic diagnostic x-ray system) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Philips Electronics Australia 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-00812-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2014-07-22
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00812-1
  • 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
    As result of a faulty automatic motion controller (amc), a problem in the power on self test (post) error handling was detected, which can result in a hazardous movement of the c-arc. this can only occur during startup of the system. when the problem in the post error handling during startup occurs, the c-arc might move unexpectedly. the image detector (which is connected to the same amc axis motion controller) may also move unexpectedly. the issue does not occur at every startup and is only present if a post-error handling is detected during the post phase.
  • 조치
    Philips is advising that the user must be cautious for any unexpected movement of the C-arc and Image Detector when a system start-up (cold restart) is required during a procedure to protect their own safety and the safety of the patient on the table. Philips field service engineers will install software release R8.2.0.3 which addresses the Positioning Software to respond properly to this error reported by the AMC motion controller during startup of the system. This action has been closed on 05/08/2016.

Device

Allura Xper R8.2.0 (Fluoroscopic diagnostic x-ray system)

Manufacturer

Philips Electronics Australia Ltd
  • 제조사 모회사 (2017)
    Philips
  • Source
    DHTGA