BEUDAMED
    FDA Enforcement Class II Terminated

    Juno DRF System. Mobile X-ray system These are general, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures

    Recall: Z-2160-2013 · Reported September 25, 2013

    Enforcement

    Recall Number
    Z-2160-2013
    Event ID
    66024
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Villa Radiology Systems LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 25, 2013
    Initiation Date
    August 2, 2013
    Classification Date
    September 13, 2013
    Termination Date
    July 25, 2016
    Address
    91 Willenbrock Rd Ste B1, N/A, Oxford, CT, 06478-1036, United States

    Description

    Juno DRF System. Mobile X-ray system These are general, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures

    Reason

    It has been discovered that the Air Kerma rate information is inconsistent in Continuous Fluoro modes 30x30 (12"x12") and 15x15 (6"x6). This could result in a deviation of the displayed values of Air Kerma Rate and Cumulated Air Kerma from the actual values greater then +/-35% and then in a failure to comply with the requirements of 21 CFR 1020.32(k)(6

    Code Info

    PN 709020

    Distribution

    US Distribution including the states of AZ, MI, IN, UT, CT, AL, NY, PA, IL, MD, CA, MA, IA, OH, MS and MO.

    Quantity

    22 units within US