BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-0878-2017 · Reported December 28, 2016

    Enforcement

    Recall Number
    Z-0878-2017
    Event ID
    75909
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Merge Healthcare, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Other
    Report Date
    December 28, 2016
    Initiation Date
    October 8, 2015
    Classification Date
    December 21, 2016
    Termination Date
    June 22, 2018
    Address
    900 Walnut Ridge Dr, N/A, Hartland, WI, 53029-8347, United States

    Description

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

    Reason

    Measurements in the software are changing after saving a plan with a measurement result, which may result in potential patient injury or delay in diagnosis or treatment.

    Code Info

    Versions: 2.0, 2.1, 2.1.1, 3.1, 3.2, 3.2.4, 3.3, 3.3.1, 3.4, 3.5.1, 3.5.1.1, 3.5.2, 3.5.3, 3.5.4, 3.5.5, 3.6, 3.6.1, 3.6.2, 3.7, 3.7.1, 3.7.2, 3.7.2 Vet, and 3.7.3

    Distribution

    Distribution was made to medical facilities in CA, CO, CT, MA, MD, MN, MT, NE, NV, NY NJ, PA, SC, WA, and WI. Foreign distribution was made to Canada, as well as other countries.

    Quantity

    30 sites potentially have the effected versions