BEUDAMED
    FDA Recall Terminated

    Merge PACS software. Product was distributed under the AMICAS label, Brighton, MA, but labeling was later changed to Merge Healthcare, Hartland, WI.

    Recall: Z-2379-2016 · Initiated January 30, 2016

    Recall

    Recall Number
    Z-2379-2016
    Event Number
    74773
    Firm
    Merge Healthcare, Inc.
    FEI Number
    1000116130
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    January 30, 2016
    Terminated
    October 5, 2020
    Address
    900 Walnut Ridge Dr, Hartland, WI, 53029-8347

    Description

    Merge PACS software. Product was distributed under the AMICAS label, Brighton, MA, but labeling was later changed to Merge Healthcare, Hartland, WI.

    Reason

    The patient name in the Halo title bar and the thumbnails do not match the name on displayed images.

    Action

    The recalling firm issued a letter dated 1/27/2016 via e-mail on 1/30/2016 explaining the reason for recall and instructing the customer to provide a copy of the notification to all users. A second letter was issued to nonresponders dated 5/25/2016

    Distribution

    The software was distributed to medical facilities nationwide. Government distribution was made to MN. Foreign distribution was made to Australia and to the United Kingdom. There was no military distribution.

    Quantity

    93 sites have the affected version