BEUDAMED
    FDA Enforcement Class II Terminated

    Merge PACS software. The firm name on the label is Merge Healthcare, Inc., Hartland, WI. Intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images.

    Recall: Z-2363-2016 · Reported August 17, 2016

    Enforcement

    Recall Number
    Z-2363-2016
    Event ID
    74776
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Merge Healthcare, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    August 17, 2016
    Initiation Date
    February 5, 2016
    Classification Date
    August 8, 2016
    Termination Date
    October 25, 2016
    Address
    900 Walnut Ridge Dr, Hartland, WI, 53029-8347, United States

    Description

    Merge PACS software. The firm name on the label is Merge Healthcare, Inc., Hartland, WI. Intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images.

    Reason

    When measuring a lesion on an unmagnified mammography image then performing the same measurement on an image magnified by the Hologic imager (different image), the measurements are not the same.

    Code Info

    Software versions 6.0.2.0 MR2, 6.0.3.0 MR3, 6.0.3.1 MR3 CU1

    Distribution

    Worldwide Distribution -- USA and Australia.

    Quantity

    49 sites potentially have the affected versions