Events

Kodak DirectView DR 7500 System with software version 5.3 (diagnostic x-ray system) 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-2014-RN-00031-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-01-17
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00031-1
  • 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
    There were two incidents in the united states where the previous patient image was displayed on the console with the current patient's name. carestream health has determined that this only occurs when the user interrupts the daily offset refresh detector calibration by switching the active detector from one bucky to another (e.G. table to the wall) and cancels detector calibration within 30 seconds of initiating this process. there have been no reports of misdiagnosis or injuries related to this issue.
  • 조치
    Carestream Health is recommending that the daily detector calibration process should not be interrupted once initiated and completed only when patients are not being imaged. Carestream Health is installing the software modification as a permanent correction.

Device

Kodak DirectView DR 7500 System with software version 5.3 (diagnostic x-ray system)
  • 모델명 / 제조번호(시리얼번호)
    Kodak DirectView DR 7500 System with software version 5.3 (diagnostic x-ray system)ARTG Number: 136112
  • Manufacturer
    Carestream Health Australia Pty Ltd

Manufacturer

Carestream Health Australia Pty Ltd