IMPAX 5.2 DB Server, version 5.2 (Picture archiving and communication system, PACS) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 AGFA HealthCare Australia 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-00317-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2013-04-18
  • 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
    System downtime and/or slow performance may result if software in use is not at supported levels. to be specific, it has been identified that oracle version 10.1.0.4.0 or older in use with impax 5.2 db server can cause oracle blocking sessions due to defect 360595 with fix available in oracle 10.2.0.2 and subsequent versions.
  • 조치
    Agfa HealthCare is advising that the ‘End of Service Life’ for IMPAX 5.2 was December 31, 2010. In order for Agfa HealthCare to continue to provide support, it is critical that sites upgrade to the latest version of IMPAX. In the interim, Agfa HealthCare strongly recommends installing the latest Oracle critical patch upgrades. Please see Oracle’s website for more details: http://www.oracle.com/technetwork/database/windows/downloads/index-101290.html .

Device

  • 모델명 / 제조번호(시리얼번호)
    IMPAX 5.2 DB Server, version 5.2 (Picture archiving and communication system, PACS)ARTG Number: 127983
  • 의료기기 분류등급
  • Manufacturer

Manufacturer