Allura Xper R7.2.x (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-2015-RN-00122-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-02-13
  • 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
    In certain circumstances, a software error can lead to a situation where the five minute fluoroscopy audible signal does not sound, as is required. no injuries attributed to the problem are reported.
  • 조치
    Philips Healthcare is advising the user to always observe realtime dose information and cumulative fluoro time provided by the system. The fault condition is reset when a new patient case is started or when the system is restarted. Philips Healthcare service engineers will install software release R7.2.8 which addresses the buzzer issue. This action has been closed-out on 3/8/2016.

Device

  • 모델명 / 제조번호(시리얼번호)
    Allura Xper R7.2.x (Fluoroscopic diagnostic x-ray system)Product codes: 722003, 722005, 722006, 722008, 722014, 722015 with system software release 7.2.xARTG Number:175708
  • Manufacturer

Manufacturer

  • 제조사 모회사 (2017)
  • Source
    DHTGA