BEUDAMED
    FDA Enforcement Class II Ongoing

    Omnera 400A Digital Radiographic System

    Recall: Z-1332-2022 · Reported July 13, 2022

    Enforcement

    Recall Number
    Z-1332-2022
    Event ID
    90446
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Arcoma AB
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 13, 2022
    Initiation Date
    May 5, 2021
    Classification Date
    July 5, 2022
    Address
    Annavagen 1, N/A, Vaxjo, N/A, N/A, Sweden

    Description

    Omnera 400A Digital Radiographic System

    Reason

    There is the potential for the X-Ray system to short circuit due to an ingress of liquid in the display handles which may result in uncontrolled movement of the Overhead Tube Crane (OTC).

    Code Info

    UDI/DI: 07350008750012; 2001-2003, 2006-2044, 2046-2056, 2118-2126, 2128-2131, 2134-2160, 2164-2175, 2177-2195, 2197-2208, 2210-2212, 2214-2224, 2226-2236.

    Distribution

    US Nationwide distribution in the states of NM, DE, TX, VT, FL, MO, UT, PA, OR, IN, RI, MI, IL, LA, OH, CO, SC, VA, WA, CA, AZ, NV, AR and the country of Canada.

    Quantity

    47 systems