BEUDAMED
    FDA Recall Terminated

    Merge RadSuite software. Radiological image processing system.

    Recall: Z-2715-2016 · Initiated April 9, 2015

    Recall

    Recall Number
    Z-2715-2016
    Event Number
    74853
    Firm
    Merge Healthcare, Inc.
    FEI Number
    1000116130
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    April 9, 2015
    Posted
    September 2, 2016
    Terminated
    August 24, 2017
    Address
    900 Walnut Ridge Dr, Hartland, WI, 53029-8347

    Description

    Merge RadSuite software. Radiological image processing system.

    Reason

    When RadSuite is used with IPID (Issuer of Patient ID) as a part of the "Patient Identifier," it is possible in some circumstances that the demographics of one patient will be applied to a study or studies for another patient.

    Action

    The recalling firm issued letters dated 4/3/2015 via email on 4/9/2015 notifying the customer of the issues.

    Distribution

    Distribution was made to medical facilities in AL, MI, MO, PA, TN, and TX.

    Quantity

    10 sites have the affected software that is configured with the specific conditions listed in Code Information