All Giraffe Carestation Beds shipped between 18 September 2015 and 1 November 2015 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-2015-RN-01233-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2015-12-21
  • 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
    If the clear patient history prompt is not responded to, the previous patient's weight could be displayed on the giraffe carestation user interface.This could cause clinical decisions to be made based on the weight associated with the wrong patients, which in turn could lead to clinical decisions which could require medical intervention.There have been no injuries reported as a result of this issue.
  • 조치
    GE Healthcare is providing work around instructions for users to follow as an interim measure. A software upgrade will be provided as a permanent correction. This action has been closed-out on 29/08/2016.

Device

  • 모델명 / 제조번호(시리얼번호)
    All Giraffe Carestation Beds shipped between 18 September 2015 and 1 November 2015Giraffe Incubator Carestation Serial Numbers: TAAU67001, TAAU67002, TAAU67003, TAAU67004, TAAU67006, TAAU67007, TAAU67011, TAAU67012Giraffe OmniBed Carestation Serial Numbers: TABU67001, TABU67002, TABU67003, TABU67005, TABU67006, TABU67007, TABU67008, TABU67009, TABU67011 ARTG Number: 139289
  • Manufacturer

Manufacturer