BEUDAMED
    FDA Recall Terminated

    Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI.

    Recall: Z-1176-2017 · Initiated April 4, 2016

    Recall

    Recall Number
    Z-1176-2017
    Event Number
    76260
    Firm
    Merge Healthcare, Inc.
    FEI Number
    1000116130
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    April 4, 2016
    Terminated
    April 8, 2019
    Address
    900 Walnut Ridge Dr, Hartland, WI, 53029-8347

    Description

    Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI.

    Reason

    Potential exists for an incorrect patient image being displayed which could result in the delay in diagnosis or treatment.

    Action

    The recalling firm issued a letter dated 3/28/2016 via email on 4/4/2016 or via certified mail if they did not have an email address for the customer. A second letter was issued 7/11/2016 to nonresponders.

    Distribution

    Distribution was made to medical facilities in AZ, CA, CO, FL, HI, IL, MA, MD, MI, MO, NY, OH, PA, SC, TN, UT, and WI. There was no foreign/government/military distribution.

    Quantity

    29 sites have the potentially affected software