Centricity PACS RA1000 Workstation (Picture Archiving and Communication System) 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-00868-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2013-08-26
  • 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
    Ge healthcare has become aware of potential safety issues due to out of context and measurement issues associated with specific workflows of centricity pacs ra1000 workstations.
  • 조치
    GE Healthcare are providing a software update to correct the issue (version 4.0 SP3).The update can only be applied to versions 3.2.X and 4.01. Customers on previous versions must first upgrade to 3.2 before applying update 4.0 SP3. Once 4.0 SP3 (FMI 85285) is released, all media required to upgrade from 3.1.1.2 to 3.2 to 4.0 SP3 are included in the FMI 85285 media kit. Thia action has been closed on 28/01/2016

Device

  • 모델명 / 제조번호(시리얼번호)
    Centricity PACS RA1000 Workstation (Picture Archiving and Communication System)All Versions below 4.0.3ARTG Number: 120196
  • Manufacturer

Manufacturer