Events

CENTRICITY PACS WORKSTATION - SOFTWARE 의 리콜

Health Canada (via FOI)에 따르면, 해당 리콜 는 Canada 에서 GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE) 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
    95009
  • 사례 위험등급
    II
  • 사례 시작날짜
    2008-12-22
  • 사례 국가
    Canada
  • 사례 출처
    HC
  • 비고 / 경고
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • 데이터 추가 비고
  • 원인
    When using f12 key to mark patient study as completed a different report for a different study is being assigned to that study. when f12 pressed before report palette updated with selected study info.

Device

CENTRICITY PACS WORKSTATION - SOFTWARE
  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: K2004SR (Lot serial: S/N'S 2855II9 J16LX11); Model Catalog: K2022JA (Lot serial: 8WZFY11 F37C921 78550II1); Model Catalog: K2004SR (Lot serial: 8WZFY11 F37C921 78550II1); Model Catalog: K2022JA (Lot serial: GRZBX11 GY5KY11 BPWCY11); Model Catalog: K2004SR (Lot serial: GRZBX11 GY5KY11 BPWCY11); Model Catalog: K2022JA (Lot serial: BZL8Z01 BZOT211 B7NWZ11); Model Catalog: K2004SR (Lot serial: BZL8Z01 BZOT211 B7NWZ11); Model Catalog: K2022JA (Lot serial: S/N'S 2855II9 J16LX11)
  • 제품 설명
    CENTRICITY PACS WORKSTATION - SOFTWARE
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)