Barco Surgical Displays 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Barco Systems 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-2015-RN-00512-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-06-22
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 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
    The surgical display types listed above could lose the user- defined settings, including failover, under the following condition:after being in stand-by mode or being in autosearch mode for at least an accumulative time of 4,152 hours (173 calendar days) and the unit is powered off and back on, or went into stand-by mode and back on. the accumulative time does not need to be continuous. one of the lost settings is the user setting for automatic failover switching.Barco has investigated this behaviour and confirms that both the failover mode and user (defined) profile settings will indeed be lost on the products involved. however, the factory settings are never lost.The behaviour is caused by a firmware issue on the barco surgical displays listed below.
  • 조치
    As a short term solution Barco is recommending that end users either: - Verify the correctness of the failover mode setting in the user settings before each use; or - Disable the failover mode in the user settings of the OSD and if needed switch manually to the backup source. With this intermediate fix, the display can continue its normal operation, until the final corrective action will be implemented. Barco is currently validating a new firmware version which will fix the issue. This action has been closed-out on 22/08/2016.

Device

  • 모델명 / 제조번호(시리얼번호)
    Barco Surgical DisplaysSurgical Display MDSC-2224 (24 inch) Part Numbers K9307912, K9307913, K9307916 and K9307917Surgical Display MDSC-2226 (26 inch) Part Numbers K9307906, K9307907 and K9307908Surgical Display MDSC-2242 (42 inch) Part Numbers K9307914 and K9307915
  • Manufacturer

Manufacturer

  • 제조사 모회사 (2017)
  • Source
    DHTGA