Events

Philips BV25, BV300, BV Libra, BV Endura, BV Pulsera (Fluoroscopic x-ray systems) 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-2016-RN-01183-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2016-09-13
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01183-1
  • 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 has been notified regarding an issue with the x-ray "on" label for systems supplied in south australia. the colour of the exposure indicator on the control panel is same as the background text. hence, systems do not meet south australia's radiation protection and control regulation.This issue has been evaluated for radiation hazard and concluded that there is no safety impact to the patient, user or bystander. it is a regulatory non-compliance issue in south australia. this issue has been evaluated for potential radiation hazard and concluded that there is no safety impact to the patient, user or bystander.
  • 조치
    Philips will be applying a red transparent label over the existing x-ray symbol on the control panel as a permanent correction in the affected systems in South Australia. In the interim, users are advised that there is an indicator lamp on Mobile Viewing Station which glows whenever x-ray exposure happens. The user should use this indication to be able to know when an exposure happens. This action has been closed-out on 24/05/2017.

Device

Philips BV25, BV300, BV Libra, BV Endura, BV Pulsera (Fluoroscopic x-ray systems)
  • 모델명 / 제조번호(시리얼번호)
    Philips BV25, BV300, BV Libra, BV Endura, BV Pulsera (Fluoroscopic x-ray systems)System: BV25Model Number: 718015System: BV300Model Numbers: 71815, 71816, 71819System: BV LibraModel Numbers: 718022, 718030, 718031System: BV EnduraModel Numbers: 718071, 718072, 718073, 718074System: BV PulseraModel Number: 718094ARTG Number: 98556
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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