BEUDAMED
    FDA Enforcement Class II Terminated

    Merge RadSuite software. Radiological image processing system.

    Recall: Z-2715-2016 · Reported September 14, 2016

    Enforcement

    Recall Number
    Z-2715-2016
    Event ID
    74853
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Merge Healthcare, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    September 14, 2016
    Initiation Date
    April 9, 2015
    Classification Date
    September 2, 2016
    Termination Date
    August 24, 2017
    Address
    900 Walnut Ridge Dr, Hartland, WI, 53029-8347, United States

    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.

    Code Info

    RadSuite Versions: 5.30.8, 5.35.3, 5.35.4, 5.35.5, 8.30.7.3, 8.30.7.4, 8.30.7.5, 8.30.7.7 are affected, BUT ONLY if they are configured with all of the following conditions: (1) Must have IPID enabled; (2) Must use IPID morphers (3) Must Define a Defaultvalue in the IPID Morpher; (4) Must use the Aggregating Morpher; (5) Must not set OverwritelfPresent=false; and (6) Must be on an internal store (this is data that is already present on EA being stored to Radsuite, this excludes direct DICOM stores to the EA).

    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