BEUDAMED
    FDA Recall 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 · Initiated February 5, 2016

    Recall

    Recall Number
    Z-2363-2016
    Event Number
    74776
    Firm
    Merge Healthcare, Inc.
    FEI Number
    1000116130
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    February 5, 2016
    Terminated
    October 25, 2016
    Address
    900 Walnut Ridge Dr, Hartland, WI, 53029-8347

    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.

    Action

    The recalling firm's customer support notified customers via phone call beginning 2/5/2016 to inform them of the issue. Customers were informed that a software fix that corrects the issue was available. Customers were asked not to use the measurements on mammo images until upgraded. If customers want an upgrade, then someone would contact them to schedule the upgrade.

    Distribution

    Worldwide Distribution -- USA and Australia.

    Quantity

    49 sites potentially have the affected versions