Events

Recall of Device Recall Apollo DRF

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Villa Radiology Systems LLC.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    73459
  • Event Risk Class
    Class 2
  • Event Number
    Z-1065-2017
  • Event Initiated Date
    2016-02-19
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144237
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Table, radiologic - Product Code KXJ
  • 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.

Device

Device Recall Apollo DRF
  • Model / Serial
    08090531 09090591 10040680 15051450 11020798
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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
  • Product Description
    Apollo DRF: Model: 9784220831 || Multi-function x-ray systems capable of routine radiograph and general fluoroscopy procedures.
  • Manufacturer
    Villa Radiology Systems LLC

Manufacturer

Villa Radiology Systems LLC
  • Manufacturer Address
    Villa Radiology Systems LLC, 91 Willenbrock Rd Ste B1, Oxford CT 06478-1036
  • Manufacturer Parent Company (2017)
    Villa Radiology Systems Llc
  • Source
    USFDA