BEUDAMED
    FDA Enforcement Class II Terminated

    Apollo DRF; Model: 9784220831 Product Usage: General, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures

    Recall: Z-1429-2017 · Reported March 15, 2017

    Enforcement

    Recall Number
    Z-1429-2017
    Event ID
    76367
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Villa Sistemi Medicali S.P.A.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 15, 2017
    Initiation Date
    December 27, 2016
    Classification Date
    March 9, 2017
    Termination Date
    March 9, 2021
    Address
    Via delle Azalee 3, N/A, Buccinasco, N/A, N/A, Italy

    Description

    Apollo DRF; Model: 9784220831 Product Usage: General, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures

    Reason

    Patient fell from the table because the footrest of the device detached from the table top while the patient was positioned on the table and table was moving from vertical position.

    Code Info

    08090531 09090591 10040680 15051450 11020798

    Distribution

    US Nationwide distribution in the states of AL, AZ, CA, CO, CT, DC, FL, IA, IL, IN, LA, MA, MD, MI, MN, MO, MS, NJ, NY, PA, Puerto Rico, TN, TX, UT, and W.I

    Quantity

    65 devices in total