BEUDAMED
    FDA Enforcement Class II Terminated

    Villa Sistemi Rotograph EVO 3D X-ray

    Recall: Z-0128-2016 · Reported November 18, 2015

    Enforcement

    Recall Number
    Z-0128-2016
    Event ID
    71958
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Villa Radiology Systems LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 18, 2015
    Initiation Date
    August 5, 2015
    Classification Date
    November 6, 2015
    Termination Date
    March 22, 2017
    Address
    91 Willenbrock Rd Ste B1, N/A, Oxford, CT, 06478-1036, United States

    Description

    Villa Sistemi Rotograph EVO 3D X-ray

    Reason

    It has been discovered that due to lack of information accompanying documents the product fails to comply with 21CfR 1020.33(c),1020.33(d),1020.33(g),and 1020.330).

    Code Info

    p/n 9307251291, 9307351291, 9307651291

    Distribution

    US Distribution

    Quantity

    Rotograph EVO 3D - 8 installed