BEUDAMED
    FDA Enforcement Class II Ongoing

    Apollo: Models: 9784000131, 9784000231, 9784020131, 9784020231, 9784100231, 9784120131, 9784120231, 9784130131 Multi-function x-ray systems capable of routine radiograph and general fluoroscopy procedures.

    Recall: Z-1064-2017 · Reported February 1, 2017

    Enforcement

    Recall Number
    Z-1064-2017
    Event ID
    73459
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Villa Radiology Systems LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 1, 2017
    Initiation Date
    February 19, 2016
    Classification Date
    January 20, 2017
    Address
    91 Willenbrock Rd Ste B1, N/A, Oxford, CT, 06478-1036, United States

    Description

    Apollo: Models: 9784000131, 9784000231, 9784020131, 9784020231, 9784100231, 9784120131, 9784120231, 9784130131 Multi-function x-ray systems capable of routine radiograph and general fluoroscopy procedures.

    Reason

    The analysis showed that the incident was caused by a chain of four faults: 1.) The injured person overcame a physical barrier (the tabletop support arm. height ca. 60 em) to access a prohibited area not intended as a working position. 2) The directions for use (device labeling and instructions for use) did not contain an explicit exclusion of the prohibited area. 3.) The movement was activated inadvertently and continuously. and it was not released (the movement requires continuous activation). 4.) Delayed activation of the emergency stop.

    Code Info

    06040078 07030172 06090116 06110138 07010149 07020158 07020162 07020163 07020165 07030168 07030171 07040206 09090605 10100752 06060086 06100127 09010566 08020473 11100873 15041446

    Distribution

    AL AZ CA CO CT DC FL IA IL IN LA MA MD MI MN MO MS NJ NY OH PA Puerto Rico TN TX UT WI

    Quantity

    66 distributed in US