Events

Dash 3000/4000/5000 (multiparameter patient monitor) & Dash Port 2 (docking station for Dash 3000/4000/5000) 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-00155-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-02-28
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00155-1
  • 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 identified several potential safety issues with the dash 3000/4000/5000 patient monitors and the dash port 2 docking station.The dash 3000/4000/5000 patient monitors may encounter the following issues:- dash stops communicating on the unity network resulting in loss of monitoring at the carespace cic pro central station.- dash displays distorted ecg waveforms in combination monitoring mode- dash date reverts to 1993the dash port 2 stops communicating on the unity network resulting in loss of monitoring at the carespace cic pro central station.
  • 조치
    GE Healthcare is developing a software correction and will provide to customers once development has been completed. In the interim end users have been requested to follow work around instructions to help mitigate the issues. Thia action has been closed out on 28/01/2016.

Device

Dash 3000/4000/5000 (multiparameter patient monitor) & Dash Port 2 (docking station for Dash 3000...
  • 모델명 / 제조번호(시리얼번호)
    Dash 3000/4000/5000 (multiparameter patient monitor) & Dash Port 2 (docking station for Dash 3000/4000/5000)Dash networked units with product codes EH, AAB, DSH, SBG, SHQ and SD0 in the serial number Dash Port 2 units with product code SE5 in the serial numberARTG number 92726
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd