Events

GE Carescape Patient Monitor B650 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 GE Healthcare Finland Oy 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
    15582
  • 사례 시작날짜
    2013-11-06
  • 사례 국가
    New Zealand
  • 사례 출처
    NZMMDSA
  • 사례 출처 URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • 비고 / 경고
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • 데이터 추가 비고
    Recalling Organisation: GE Healthcare Limited, 8 Tangihua Street, Auckland 1010
  • 원인
    The manufacturer has determined that selected software versions of b650 and b850 patient monitors have a number of safety related issues including:, 1. non-invasive blood pressure (nibp) auto-cycling will not start, 2. nibp auto-cycling stops when selecting audio & display off, 3. nibp auto-cycling stops when loading data and measuirng nibp at the same time, 4. lost nibp measurements, 5. nibp limit values for infants change when loading a new patient data from a tram module, 6. wrong ecg bandwith in e-psm(p) or e-(p)re(s)tn modules, 7. changing the primary ecg lead selection in the cic pro central station will not change the primary measurement lead in pdm or tram measurement modules, 8. a temp hidden alarm message will not re-activate if a different alarm is acknowledged at icentral, 9. missing audible alarms from remote monitors after broken network connection, 10. missing ecg waveforms on icentral., 11. icentral does not notice a monitor exiting the standby mode, + 14 other issues.
  • 조치
    Software to be upgraded

Device

GE Carescape Patient Monitor B650
  • 모델명 / 제조번호(시리얼번호)
    Model: Model: B650, Affected: S/W versions 1.1.12 and earlier
  • Manufacturer
    GE Healthcare Finland Oy

Manufacturer

GE Healthcare Finland Oy