Events

CARESCAPE MONITOR B850 SYSTEM - C1 CPU W/THIRD VIDEO 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
    18137
  • 사례 위험등급
    III
  • 사례 시작날짜
    2012-05-29
  • 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
    The monitor may enter into a constant boot loop causing it to reboot continuously and will cause loss of overall monitoring and may lead to delayed treatment. when the usb cable connected to the carescape monitor b850 cpu or display is insecurely connected or faulty and is able to move the monitor may reboot. reboot may also happen if the display is continuously set on and off several times. the reboot will cause loss of overall monitoring and may lead to delayed treatment. there is a remote printing issue with currently printing prn 50 recorder. if the recorder prn 50 is currently printing when carescape monitor b850 sends printing request to that prn 50 the printing will be saved only after 12 seconds. the print job will be printed after the printer is ready if the waiting time is less than 30 seconds. b) when the user starts the printing from cic pro to the prn 50 located at the cic pro the printing jobs are printed locally at the bedside if the network prn 50 is busy. the monitor reboots due to an x server freeze and may reboot when the monitor is viewed from cic pro or when the printing is initiated from cic pro.

Device

CARESCAPE MONITOR B850 SYSTEM - C1 CPU W/THIRD VIDEO
  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: 2020913-003 (Lot serial: all); Model Catalog: 2020913-002 (Lot serial: all)
  • 제품 설명
    CARESCAPE MONITOR B850 SYSTEM - C1 CPU W/THIRD VIDEO
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)