Events

Rappel de GE Carescape Patient Monitor B650

Selon New Zealand Medicines and Medical Devices Safety Authority, ce/cet/cette rappel concerne un dispositif en/au/aux/à New Zealand qui a été fabriqué par GE Healthcare Finland Oy.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    15582
  • Date de mise en oeuvre de l'événement
    2013-11-06
  • Pays de l'événement
    New Zealand
  • Source de l'événement
    NZMMDSA
  • URL de la source de l'événement
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Recalling Organisation: GE Healthcare Limited, 8 Tangihua Street, Auckland 1010
  • Cause
    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.
  • Action
    Software to be upgraded

Device

GE Carescape Patient Monitor B650
  • Modèle / numéro de série
    Model: Model: B650, Affected: S/W versions 1.1.12 and earlier
  • Manufacturer
    GE Healthcare Finland Oy

Manufacturer

GE Healthcare Finland Oy