Allura Xper FD20 Biplane / FD20 Biplane OR table (Flouroscopic angiographic digital x-ray system) Software versions prior to 8.1.0.3 are affected 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-2013-RN-00113-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2013-02-07
  • 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
    If using the targano wheel or speed slider to increase the image speed during the replay of a vascular biplane run, with different image sized on disk in the frontal and lateral channel (1024x1024 or 2048x2048), an image processing error will occur resulting in a system hang up.
  • 조치
    Siemens is advising the customers that until the corrective action has been implemented, the Targano wheel or speed slider should not be used to effect the image speed during replay of a vascular bi-plane run. Philips is providing a software upgrade (v 8.1.0.3) to correct the issue.

Device

  • 모델명 / 제조번호(시리얼번호)
    Allura Xper FD20 Biplane / FD20 Biplane OR table (Flouroscopic angiographic digital x-ray system) Software versions prior to 8.1.0.3 are affectedProduct Codes: 722013 & 722025 ARTG number: 175708
  • 의료기기 분류등급
  • Manufacturer

Manufacturer

  • 제조사 모회사 (2017)
  • Source
    DHTGA