Events

Giraffe Incubator and Giraffe OmniBed with Servo Oxygen Control SystemManufactured between August 1 2012 and December 20 2012 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-2013-RN-00023-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2013-01-08
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00023-1
  • 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
    When the giraffe omnibed and giraffe incubator is powered "on" or there is a recovery from power failure, the oxygen set point or radiant heater set point (values that are entered by the clinician) may be overwritten due to a potential overwriting of stored information associated with the display printed circuit board.
  • 조치
    GE Healthcare is advising hospitals may continue to use the affect product, however, all set points must be confirmed when powering 'on' the Giraffe microenvironment or when recovering from a power failure event. A software update will be provided by GE Healthcare to correct the issue.

Device

Giraffe Incubator and Giraffe OmniBed with Servo Oxygen Control SystemManufactured between August...

Manufacturer

GE Healthcare Australia Pty Ltd