Events

Carestream DRX Evolution with Full Featured Wall Stand, Carestream DRX Evolution with Carestream Premium Wall Stand and Kodak DirectView DR 7500 System with Full FeaturedWall Stand 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Carestream Health Australia Pty 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-2013-RN-01285-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-12-04
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01285-1
  • 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
    Carestream health australia pty ltd has received advice that there were three incidents (one in australia and two in the united states) where the wall stand (bucky) continued its downward movement despite the radiographer/operator releasing the motorised wall stand (ws) keypad button which controls the downward movement. this can result in the wall stand contacting a patient's legs or feet.
  • 조치
    Carestream Australia is conducting a field action to apply a label to remind users of the location of the emergency stop button and to inspect and install a bracing bracket for the motorised wall stand (bucky) keypad or replace keypad if deemed necessary by Carestream's service engineer.

Device

Carestream DRX Evolution with Full Featured Wall Stand, Carestream DRX Evolution with Carestream ...
  • 모델명 / 제조번호(시리얼번호)
    Carestream DRX Evolution with Full Featured Wall Stand, Carestream DRX Evolution with Carestream Premium Wall Stand and Kodak DirectView DR 7500 System with Full FeaturedWall StandSerial numbers: 4000 – 5160 and 75000103 - 75000944ARTG number: 136112
  • Manufacturer
    Carestream Health Australia Pty Ltd

Manufacturer

Carestream Health Australia Pty Ltd