Events

CARESCAPE Monitor B650 Software Versions: 1.1.12.26 or earlier 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 GE Healthcare 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-00594-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2014-05-29
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00594-1
  • 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
    Ge healthcare has recently become aware of a potential safety issue due to possible sound loss associated with the carescape monitor b650. when an external display is connected to the carescape monitor b650 using a usb extender cable with an active usb hub, the system may experience a sound loss including alarm sounds from the patient monitor. this may occur if the external display is powered off and on during normal operation of the monitor.
  • 조치
    GE is advising their customers that this issue can be avoided by not switching the external display off and then switching it back on during normal monitor use and by not using a USB extender cable with active hub. If the sound loss occurs during normal operation of the monitor, users can enable the sounds back on by restarting the monitor. A software patch will be provided to correct this issue permanently.

Device

CARESCAPE Monitor B650 Software Versions: 1.1.12.26 or earlier

Manufacturer

GE Healthcare Australia Pty Ltd