Events

Recall of Device Recall Wall Mounting Plate

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

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
    57500
  • Event Risk Class
    Class 2
  • Event Number
    Z-1559-2011
  • Event Initiated Date
    2010-12-20
  • Event Date Posted
    2011-03-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-08-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96390
  • 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
    Unit, x-ray, extraoral with timer - Product Code EHD
  • Reason
    The x-ray unit may break loose from the mounting plate and fall off the wall due to defects in the mounting plate.
  • Action
    The firm, Gendex, sent an "URGENT MEDICAL DEVICE FIELD CORRECTION" letter dated December 20, 2010 to their customers. A revised notification letter dated January 20, 2011, was sent to the customers providing further clarification on instruction to correct the problem, as well as a template for end user notification. The letters described the product, problem and actions to be taken. The customers were instructed to contact their customers, inform them of the issue and replace the wall-mounting plate. The customers were also instructed to complete and return the attached acknowledgement form via fax to 215-997-5665 Attn: Regulatory Affairs or email to: regulatory.affairs@gendex.com and contact Gendex Customer Service at 1-800-323-8029. If you have any questions or concerns, contact the Regulatory Affairs Associate at 847-364-3290 or regulatory.affairs@gendex.com.

Device

Device Recall Wall Mounting Plate
  • Model / Serial
    part numbers D800WPEXPERT, D800WP, EXPERTDC55 NAWP, EXPERTDC65 NAWP and EXPERTDC75 NAWP distributed between April 12, 2010 and May 13, 2010
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA and countries including: Australia, Canada and Germany.
  • Product Description
    Wall Mounting Plate, an accessory to the Gendex eXpert DC (REF 110-0205G1) and 765DC (REF 110-0155G1)Intraoral X-Ray Systems; Gendex Dental Systems, Des Plaines, IL USA || The wall mounting plate is used to install the Master Control unit of the X-ray system to two wooden wall studs spaced at 16", or to a wall supported by steel studs.
  • Manufacturer
    Gendex Dental Systems

Manufacturer

Gendex Dental Systems
  • Manufacturer Address
    Gendex Dental Systems, 901 W Oakton St, Des Plaines IL 60018-1843
  • Source
    USFDA