BEUDAMED
    FDA Enforcement Class II Terminated

    Apollo; Models: 9784000131 9784000231 9784020131 9784020231 9784100231 9784120131 9784120231 9784130131 Product Usage: General, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures.

    Recall: Z-1428-2017 · Reported March 15, 2017

    Enforcement

    Recall Number
    Z-1428-2017
    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; Models: 9784000131 9784000231 9784020131 9784020231 9784100231 9784120131 9784120231 9784130131 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

    Serial Numbers: 06100127 06110138 07010149 07020158 07020163 07020165 07030171 07040206 09010566 09090605 10100752 11100873 15041446

    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