Events

Allura Xper Systems(Fluoroscopic angiographic digital 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-01104-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2014-10-10
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01104-1
  • 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
    If a footswitch is frequently used on an anti-fatigue mat, on a not flat surface or in the pedestal, the footswitch pedals may get bent. this might cause an intermittent or continuous inability of making live fluoroscopy images or exposures. in case the fluoroscopy pedal is bent and live fluoroscopy is not available, the exposure pedal of the footswitch or the hand switch may be used to generate a live image in order to finish a procedure, this will lead to a higher dose but it outweighs the potential safety risk.
  • 조치
    Philips Healthcare is advising the customers to check the footswitch for bent pedals before the start of a procedure and if bent pedals are found the procedure should not continue and local Service should be contacted. Philips Healthcare is performing the hardware update of the Footswitch in order to prevent bent pedals and therefore prevents an intermittent or continuous inability of making live fluoroscopy images or exposures. This action has been closed-out on 11/08/2016.

Device

Allura Xper Systems(Fluoroscopic angiographic digital x-ray system)
  • 모델명 / 제조번호(시리얼번호)
    Allura Xper Systems(Fluoroscopic angiographic digital x-ray system)Multiple Product Codes and Serial NumbersARTG Number: 175708
  • 의료기기 분류등급
    Radiology Devices
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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