Events

Recall of Device Recall CIC Pro v4.1

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by General Electric Medical Systems Information Technology.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    45454
  • Event Risk Class
    Class 2
  • Event Number
    Z-0280-2008
  • Event Initiated Date
    2007-01-24
  • Event Date Posted
    2008-02-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=65487
  • Notes / Alerts
    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.
  • Extra notes in the data
    Central Station Monitoring System - Product Code DSI
  • Reason
    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
  • Model / Serial
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    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
  • Product Description
    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
  • Manufacturer Address
    General Electric Medical Systems Information Technology, 8200 W Tower Ave, Milwaukee WI 53223-3219
  • Source
    USFDA