Events

Rappel de Device Recall CIC Pro v4.1

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 General Electric Medical Systems Information Technology.

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
    45454
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0280-2008
  • Date de mise en oeuvre de l'événement
    2007-01-24
  • Date de publication de l'événement
    2008-02-01
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-05-16
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=65487
  • 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
    Central Station Monitoring System - Product Code DSI
  • Cause
    Two separate issues may occur with operating the cic pro v4.1 system with telemetry. 1) experience a loss of audible alarms when operating system memory resource reaches approximately 170mg. this will occur if cic pro continuously runs for average of 160 day, and 2) system may continuously reboot upon start up in an attempt to correct the issue.
  • Action
    GE Healthcare sent a certified letter titled "Urgent Medical Device Correction" to customers on 3/13/07. As a Short Term Solution, GE recommends that user reboot of system according to instructions and precautions in Service Manual at least once every three months. Also, take the necessary precautions to ensure that system is shut down properly. This will decrease the likelihood of a continuous reboot. If system continues to reboot, GE suggest that user contact Technical Support at 1-800-588-7044 (Press Option 2) and ask for Technical Support. As for a Long Term Solution, GE will provide a software update that will rectify the issue as soon as an upgrade is available.

Device

Device Recall CIC Pro v4.1
  • Modèle / numéro de série
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (excluding DE, HI, ID, MT, ND, SD, VT), Peurto Rico, Washington DC and including the countries of Australia, Austria, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungaria, India, Indonesia, Ireland, Israel, Italy, Japan, Korea, Kuwait, Malaysia, Malta, Netherland, New Zealand, Norway, Pakistan, Philippines, Poland, Qatar, Russia, Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, and United Kingdom
  • Description du dispositif
    GE Healthcare CIC Pro Clinical Information Center, Central Station, Software Version 4.1. (CIC Pro v4.1). GE Medical Systems Information Technologies, Inc., Milwaukee, Wisconsin (System hardware consists of a processing unit and a monitor)
  • Manufacturer
    General Electric Medical Systems Information Technology

Manufacturer

General Electric Medical Systems Information Technology
  • Adresse du fabricant
    General Electric Medical Systems Information Technology, 8200 W Tower Ave, Milwaukee WI 53223-3219
  • Source
    USFDA