BEUDAMED
    FDA Recall 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 · Initiated December 27, 2016

    Recall

    Recall Number
    Z-1428-2017
    Event Number
    76367
    Firm
    Villa Sistemi Medicali S.P.A. Via delle Azalee
    FEI Number
    3002808461
    Product Code
    KXJ
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    December 27, 2016
    Terminated
    March 9, 2021
    Address
    3 Buccinasco 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.

    Action

    Customers were notified of the recall via DHL or similar mail service. The letter identified the affected product, problem and actions to be taken.

    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