BEUDAMED
    FDA Recall Terminated

    Merge Hemo, Software packages 10.2, 10.3, and 10.4

    Recall: Z-2387-2021 · Initiated July 23, 2021

    Recall

    Recall Number
    Z-2387-2021
    Event Number
    88379
    Firm
    Merge Healthcare, Inc.
    FEI Number
    1000116130
    Product Code
    DQK
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    July 23, 2021
    Terminated
    August 29, 2023
    Address
    900 Walnut Ridge Dr, Hartland, WI, 53029-8347

    Description

    Merge Hemo, Software packages 10.2, 10.3, and 10.4

    Reason

    The firm identified a safety issue affecting the software associated with Merge Hemo versions 9.x and 10.x, used in combination with an HL7 lab interface.

    Action

    The firm issued an Urgent Field Safety Notice by email on 07/23/2021. The letter explained the issue and provided a workaround for the safe, continued use of the instrument until a software correction can be made.

    Distribution

    US distribution

    Quantity

    326 units