Events

DuraDiagnost Release 1.0, 2.0, 3.0 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-2017-RN-00726-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2017-06-01
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00726-1
  • 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 discovered via a report from the field that some welding joints on the vertical carriage brackets of the tube stand may crack. as a result, the tube arm assembly may exhibit uncharacteristic sideways movement, with the tube becoming off center. if all of the welding joints cracked, the tube arm assembly could fall down and a patient on the examination table or anyone in the vicinity could be struck by the falling tube arm assembly resulting in serious injury or death.
  • 조치
    A Philips Engineer will go on-site and inspect the welding joints of the tube stand vertical carriage brackets and install the safety hooks structure, which will prevent the tube arm assembly from falling down even if all the bracket welding joints are cracked. In the interim, users are to stop using the device.

Device

DuraDiagnost Release 1.0, 2.0, 3.0 X-Ray systems
  • 모델명 / 제조번호(시리얼번호)
    DuraDiagnost Release 1.0, 2.0, 3.0 X-Ray systemsDuraDiagnost R1.0 Product Number: 712210DuraDiagnost R2.0 and R3.0Product Number: 712211ARTG Number: 207424
  • 의료기기 분류등급
    Radiology Devices
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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