BEUDAMED
    FDA Enforcement Class II Terminated

    Juno DRF , X-ray system, diagnostic, Fluoroscopic, general-purpose Model: 70920 Product Usage: Universal R/F, general use

    Recall: Z-0702-2013 · Reported February 6, 2013

    Enforcement

    Recall Number
    Z-0702-2013
    Event ID
    63868
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips Healthcare Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 6, 2013
    Initiation Date
    December 13, 2012
    Classification Date
    January 28, 2013
    Termination Date
    January 24, 2017
    Address
    3000 Minuteman Road, Andover, MA, 01810, United States

    Description

    Juno DRF , X-ray system, diagnostic, Fluoroscopic, general-purpose Model: 70920 Product Usage: Universal R/F, general use

    Reason

    Values of fluoroscopy time, Air Kerma Rate and Cumulated Air Kerma may not be displayed "at the fluoroscopist's working position" as per 21 CFR 1003.21

    Code Info

    Serial Numbers: 10110770 11030805 11070848 11070845 11070849 11030806 11090864 11110900 12020982 114087 12030999 12061020 12041003 12061014 12061018 12081040 :

    Distribution

    US Nationwide Distribution including the states of AL, CA, CO, CT, IL, MD, MI, MO, NY, OH, PA

    Quantity

    16 units