Events

Allura Xper FD Release 8.2.16(Flouroscopic x-ray used in angiography) 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-00995-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2015-10-09
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00995-1
  • 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
    Philips healthcare has discovered through customer feedback and internal testing a software failure that could lead to an intermittent and short term unavailability of the fluoroscopy function. upon initiating fluoroscopy the user may encounter a user message “fluoro failed, please retry” and fluoroscopy will be unavailable. retrying fluoroscopy resolves this situation in most cases. you may need to retry more than once in about 2% of the events.The failure mode has no impact on an active fluoroscopy run. once started, an active fluoroscopy run continues until releasing the pedal.
  • 조치
    Philips is advising end users that they must retry fluoroscopy if the failure mode occurs. Philips Field Service Engineers will install Software R8.2.16.1 which will correct the issue. The expected date of the correction release is October 2015. This action has been closed-out on 26/08/2016.

Device

Allura Xper FD Release 8.2.16(Flouroscopic x-ray used in angiography)
  • 모델명 / 제조번호(시리얼번호)
    Allura Xper FD Release 8.2.16(Flouroscopic x-ray used in angiography) ARTG Number: 175708
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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