Events

Recall of Owandy Radiology IMAX Touch 3D

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
    71958
  • Event Risk Class
    Class 2
  • Event Number
    Z-0129-2016
  • Event Initiated Date
    2015-08-05
  • Event Date Posted
    2015-11-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-03-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139451
  • 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
    X-ray, tomography, computed, dental - Product Code OAS
  • Reason
    It has been discovered that due to lack of information accompanying documents the product fails to comply with 21cfr 1020.33(c),1020.33(d),1020.33(g),and 1020.330).
  • Action
    Villa Radiology Systems Planned Action: 1. The current users manuals have been updated and addendums to the user manuals have been developed for currently installed Rotograph Evo 3D and Imax Touch 3D. The revisions and addendums contain all information required under 21 CFR 1020.33(c), 1020.33(d), 1020.33(g), and 1020.33(j). 2. New Rotograph Evo 3D and Imax Touch 3D systems will ship with the updated user manual. 3. Addendums will be provided to all end users CDRH approves the CAP subject to the following conditions: 1. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22.

Device

Owandy Radiology IMAX Touch 3D
  • Model / Serial
    p/n 9306251191 and 9306651191
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution
  • Product Description
    Owandy Radiology I -MAX Touch 3D X-ray
  • 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