BEUDAMED
    FDA Recall Terminated

    Merge Cardio software.

    Recall: Z-1486-2017 · Initiated April 4, 2016

    Recall

    Recall Number
    Z-1486-2017
    Event Number
    76431
    Firm
    Merge Healthcare, Inc.
    FEI Number
    1000116130
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    April 4, 2016
    Terminated
    July 26, 2019
    Address
    900 Walnut Ridge Dr, Hartland, WI, 53029-8347

    Description

    Merge Cardio software.

    Reason

    Cardio study list does not show STAT studies without refreshing.

    Action

    The recalling firm issued a letter dated 3/28/2016 via e-mail the week of 4/4/2016. If no email address was available, the letters were issued via certified mail. Nonresponders were issued letters dated 7/11/2016.

    Distribution

    Distribution was nationwide to medical facilities. There was also military distribution. There was no foreign/government distribution.

    Quantity

    217 sites potentially have the affected versions