BEUDAMED
    FDA Enforcement Class II Terminated

    Merge PACS

    Recall: Z-2944-2020 · Reported September 16, 2020

    Enforcement

    Recall Number
    Z-2944-2020
    Event ID
    86205
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Merge Healthcare, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 16, 2020
    Initiation Date
    August 6, 2020
    Classification Date
    September 9, 2020
    Termination Date
    November 30, 2022
    Address
    900 Walnut Ridge Dr, Hartland, WI, 53029-8347, United States

    Description

    Merge PACS

    Reason

    Measurements done on the Merge PACS generated MPR s may have incorrect measurements.

    Code Info

    Unique Device Identifier (UDI): v8.1: PACS:(01)00842000100805(10)8.1(11)191022 OrthoPACS: (01)00842000100805(10)8.1(11)191022 v81.1: PACS: (01)00842000100805(10)8.1.1(11)200528 OrthoPACS: (01)00842000100805(10)8.1.1(11)200528 V8.1.2 PACS: (01)00842000100805(10)8.1.2(11)200709

    Distribution

    Domestic Distribution: IL, MO, NY, ND, MI, TX, FL, OH, UT, NE, MS, MN, DE, AR, CA, WI, MD, NC, NH, GA, VA, SC, PE, CT, NM, IN. International Distribution: CA, BE, UK.

    Quantity

    125 total units