BEUDAMED
    FDA Recall Terminated

    GE Healthcare CIC Pro Clinical Information Center, Central Station, Software Version 4.1. , GE Medical Systems Information Technologies, Inc., 8200 W. Tower Ave. Milwaukee, Wisconsin USA. (System hardware consists of a processing unit and a monitor)

    Recall: Z-0891-2007 · Initiated January 24, 2007

    Recall

    Recall Number
    Z-0891-2007
    Event Number
    37309
    Firm
    General Electric Medical Systems Information Technology
    FEI Number
    2124823
    Product Code
    DSI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 24, 2007
    Posted
    June 6, 2007
    Terminated
    December 10, 2011
    Address
    8200 W Tower Ave, Milwaukee, WI, 53223-3219

    Description

    GE Healthcare CIC Pro Clinical Information Center, Central Station, Software Version 4.1. , GE Medical Systems Information Technologies, Inc., 8200 W. Tower Ave. Milwaukee, Wisconsin USA. (System hardware consists of a processing unit and a monitor)

    Reason

    Alarm and Reboot problems: Two separate issues could occur with the CIC Pro system when used with Telemetry. Each issue occurs in software version v4.1 only; A) the system may experience a loss of audible alarms when operating system memory resources reach 170MB and/or B) the system may intentionally or unexpectedly reboot .

    Action

    GE Healthcare sent a certified letter titled "Urgent Medical Device Correction" to customers on 3/13/07 that explained the short and long term solutions and that the company would be providing a software update that will rectify the issue specific to CIC Pro v4.1 software.

    Distribution

    Nationwide

    Quantity

    5,190 Units