BEUDAMED
    FDA Recall Open, Classified

    Apollo DRF: Model: 9784220831 Multi-function x-ray systems capable of routine radiograph and general fluoroscopy procedures.

    Recall: Z-1065-2017 · Initiated February 19, 2016

    Recall

    Recall Number
    Z-1065-2017
    Event Number
    73459
    Firm
    Villa Radiology Systems LLC
    FEI Number
    2243757
    Product Code
    KXJ
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    February 19, 2016
    Address
    91 Willenbrock Rd, Ste B1, Oxford, CT, 06478-1036

    Description

    Apollo DRF: Model: 9784220831 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.

    Action

    Consignees were notified of the recall via letter starting on 2/19/16. The letter explains the issue and actions to be taken by the consignee and manufacturer.

    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