Events

Rappel de Centricity Perinatal (formerly Quantitative Sentinel) System Fluid Total Precision

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par GE Healthcare Integrated IT Solutions.

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
    49459
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0112-2009
  • Date de publication de l'événement
    2008-10-15
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2010-05-17
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73473
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Perinatal Monitoring System - Product Code HGM
  • Cause
    On the i&o; chart, the in, out and net fluid totals values will not honor the numeric precision configuration, always displaying a whole number, losing decimal point accuracy.
  • Action
    GE Healthcare notified their Centricity Perinatal customers via letter dated 4/20/07 of the problem with the Fluid I & O Module when fluid precision is required. The letter instructed those accounts that require fluid precision to contact GE Technical Support at 1-800-433-2009 to obtain a software patch to fix the problem. A follow-up letter dated 8/29/08 was sent on the same date to the accounts informing them that GE had re-classified the issue as a class II safety issue and that all customers need to have their software updated. The accounts were requested to contact GE Tech Support at 800-433-2009 to schedule a time to upgrade their system to 6.70.6 P02 as soon as possible. The accounts were requested to complete the enclosed customer reply form, supplying the workstation software or build number, and fax it back to 847-277-5240.

Device

Centricity Perinatal (formerly Quantitative Sentinel) System Fluid Total Precision
  • Modèle / numéro de série
    software version 6.70.6 of the Centricity Perinatal clinical information system
  • Classification du dispositif
    Obstetrical and Gynecological Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution --- including USA and country of Canada.
  • Description du dispositif
    Centricity Perinatal (formerly Quantitative Sentinel) System - Fluid Total Precision software; automatic patient data management providing clinical information at the bedside in Labor & Delivery, Mother-Baby and the Neonatal Intensive Care Unit; GE Healthcare Integrated IT Solutions, Barrington, IL 60010
  • Manufacturer
    GE Healthcare Integrated IT Solutions

Manufacturer

GE Healthcare Integrated IT Solutions
  • Adresse du fabricant
    GE Healthcare Integrated IT Solutions, 540 W Northwest Hwy, Barrington IL 60010-3051
  • Source
    USFDA