BEUDAMED
    FDA Recall Terminated

    ApexPro FH Telemetry System: composed of six major components (as follows); Accessories to the patient worn acquisition transceivers, the patient worn data acquisition transceivers, the transceiver access points with antenna, the network infrastructure, A computer platform running the ApexPro Telemetry Application and a computer platform running a central station application (which may be the same computer platform running the ApexPro Telemetry Application). GE Medical Systems information Technologies, 8200 West Tower Avenue, Milwaukee, WI 53223.

    Recall: Z-0054-2007 · Initiated June 23, 2006

    Recall

    Recall Number
    Z-0054-2007
    Event Number
    35826
    Firm
    Ge Healthcare
    FEI Number
    3005860720
    Product Code
    MHX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 23, 2006
    Posted
    October 21, 2006
    Terminated
    May 25, 2007
    Address
    9900 W Innovation Dr, Wauwatosa, WI, 53226-4856

    Description

    ApexPro FH Telemetry System: composed of six major components (as follows); Accessories to the patient worn acquisition transceivers, the patient worn data acquisition transceivers, the transceiver access points with antenna, the network infrastructure, A computer platform running the ApexPro Telemetry Application and a computer platform running a central station application (which may be the same computer platform running the ApexPro Telemetry Application). GE Medical Systems information Technologies, 8200 West Tower Avenue, Milwaukee, WI 53223.

    Reason

    System Warning Alarm failure: When a patient being monitored is in a pre-existing condition of continuous MESSAGE or ADVISORY level alarm preceding a SYSTEM WARNING level alarm, the SYSTEM WARNING audible alarm and flashing yellow border around the patient panel at the CIC does not occur.

    Action

    An Urgent Medical Device Correction letter, dated June 23, 2006, was sent to customers notifying them of the issue, provided short term recommendations and provided the long term solution as a software upgrade that will correct this situation. A reply card is asked to be returned to initiate the upgrade process.

    Distribution

    Nationwide distribution --- including states of AL, AR, AZ, CA, CO, Washington DC, FL, IL, IN, ME, MI, MN, MO, NC, NE, NJ, NY, OK, PA, SC, TX, VA, WA, WI, WV.

    Quantity

    379