BEUDAMED
    FDA Enforcement Class II Terminated

    Merge Hemo, Software packages 10.2, 10.3, and 10.4

    Recall: Z-2387-2021 · Reported September 8, 2021

    Enforcement

    Recall Number
    Z-2387-2021
    Event ID
    88379
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Merge Healthcare, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    September 8, 2021
    Initiation Date
    July 23, 2021
    Classification Date
    August 28, 2021
    Termination Date
    August 29, 2023
    Address
    900 Walnut Ridge Dr, N/A, Hartland, WI, 53029-8347, United States

    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.

    Code Info

    Version 10.2, UDI (01)00842000100430(10)10.2(11)190612 Version 10.3, UDI (01)00842000100874(10)10.3(11)200330 Version 10.4, UDI (01)00842000100966(10)10.4(11)210428

    Distribution

    US distribution

    Quantity

    326 units