Events

Allura Xper FD20 R8.2 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-2017-RN-00898-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2017-07-20
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00898-1
  • 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 identified that the protecting earth (pe) cable between a motion controller and the pe star point was not installed on the affected product.The lack of this aforementioned protective earth cable makes the system not compliant with the iec60601-1 standard for protective earthing, however there is no risk for patients / operators / users since the frame is connected to protective earth (pe) and the unit involved is shielded with a cover.The relevant parts are in the technical (equipment) room and therefore not accessible for patients. to date, philips is not aware of any injuries that may have occurred as result of this situation.
  • 조치
    Philips is requesting customers: 1. Read the supplied notice; 2. Place the notice with the documentation of the system until this correction has been implemented; and 3. Complete the supplied response form and return it to Philips via fax/email within 3 business days of receiving the customer letter.

Device

Allura Xper FD20 R8.2
  • 모델명 / 제조번호(시리얼번호)
    Allura Xper FD20 R8.2System Code: 722028Serial Number: 460ARTG Number: 225815
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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