BEUDAMED
    FDA Recall Terminated

    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)

    Recall: Z-0280-2008 · Initiated January 24, 2007

    Recall

    Recall Number
    Z-0280-2008
    Event Number
    45454
    Firm
    General Electric Medical Systems Information Technology
    FEI Number
    2124823
    Product Code
    DSI
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    January 24, 2007
    Posted
    February 1, 2008
    Terminated
    May 16, 2012
    Address
    8200 W Tower Ave, Milwaukee, WI, 53223-3219

    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)

    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.

    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

    Quantity

    6,217 Units (1,549 OUS, 4,668 within US)