Events

Philips Trauma Diagnost X-ray SystemsAll Trauma Diagnost systems delivered prior to 8th of July 2007 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-2015-RN-00735-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-08-13
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00735-1
  • 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 two of the three fixation bolts of the trauma supporting block connecting the trauma arm with the cs telescope arm are cracked out of its thread, the trauma arm is no longer fastened securely. subsequently, the 3rd bolt may easily break during normal use and the trauma arm would fall down. there is a potential that the c-arm could fall down onto the table and impact on the patient or bystander. the following factors are required for this situation to occur:- unusual wear and tear (e.G. multiple collisions)- there is more than one broken fixation screw and the user is unaware- operator is in contact with, moves, or operates the trauma arm- a person is situated below the trauma arm.
  • 조치
    A Philips Service Engineer will contact affected customers as soon as the Field Action Kit is ready to be implemented. Philips is recommending the customers not to position the ceiling suspension with the Trauma arm directly above a patient until Philips Service Engineer repairs the affected systems. This action has been closed-out on 06/09/2016.

Device

Philips Trauma Diagnost X-ray SystemsAll Trauma Diagnost systems delivered prior to 8th of July 2...
  • 모델명 / 제조번호(시리얼번호)
    Philips Trauma Diagnost X-ray SystemsAll Trauma Diagnost systems delivered prior to 8th of July 2007 are affected.ARTG Number: 100344
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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