BEUDAMED
    FDA Enforcement Class II Terminated

    Juno DFR X-ray system

    Recall: Z-1079-2015 · Reported March 18, 2015

    Enforcement

    Recall Number
    Z-1079-2015
    Event ID
    70241
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Villa Radiology Systems LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 18, 2015
    Initiation Date
    December 14, 2014
    Classification Date
    March 6, 2015
    Termination Date
    March 16, 2017
    Address
    91 Willenbrock Rd Ste B1, N/A, Oxford, CT, 06478-1036, United States

    Description

    Juno DFR X-ray system

    Reason

    The system does not provide the appropriate audible signal, permanent activation, and manual override, although the system is in high-level control functionality

    Code Info

    P/N 709020

    Distribution

    US Distribution to the states of: AZ, AL, CA, CO, CT, DC, FL, IA, IL, IN, MI, MD, MS, MA, MO, NY, OH, PA, UT, TN and TX.

    Quantity

    30 units distributed in the US