BEUDAMED
    FDA Recall Terminated

    Dinalink brand Communication Cable which is an accessory to a medical device Dinalike which is an isolated protocol converter used to concert the serial data from a DINAMAP Monitor to that of the APEXPRO telemetry transmitter.

    Recall: Z-1015-04 · Initiated January 27, 2004

    Recall

    Recall Number
    Z-1015-04
    Event Number
    28997
    Firm
    GE Medical Systems Information Technologies
    FEI Number
    1030184
    Product Code
    MHX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 27, 2004
    Posted
    July 20, 2004
    Terminated
    October 5, 2009
    Address
    4502 Woodland Corporate Blvd, Tampa, FL, 33614-2422

    Description

    Dinalink brand Communication Cable which is an accessory to a medical device Dinalike which is an isolated protocol converter used to concert the serial data from a DINAMAP Monitor to that of the APEXPRO telemetry transmitter.

    Reason

    The potential exists for external electrical noise to be processed as irregular pacing thereby masking potential asystole events.

    Action

    The firm mailed an 'Urgent Medical Device Correction' letter to consignees on January 27, 2004 advising them of the external electrical noise problem and informing them to not use the Dinalink ILC1931 with patients with pace makers until a fix or replacement can be provided. By 5/17/2004 corrective replacement cables had been provided to all consignees.

    Distribution

    Product was distributed to 7 domestic hospitals in PA, SC, GA, FL, WI, SD AND WY.

    Quantity

    36