Events

Recall of Device Recall Gendex eXpert DC Intraoral XRay System

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
    57485
  • Event Risk Class
    Class 2
  • Event Number
    Z-1248-2011
  • Event Initiated Date
    2010-12-17
  • Event Date Posted
    2011-02-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-02-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96349
  • 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
    Intraoral X-Ray System - Product Code EHD
  • Reason
    The intraoral x-ray systems were installed improperly with incorrect screws which allow the unit to pull away from the wall when the arm is fully extended. this condition may harm the patient.
  • Action
    Gendex sent a Urgent Medical Device Field Correction letter dated December 17, 2010 to the consignee, informing them that the x-ray units were installed with improper sized lag bolts and requesting that they contact Gendex Customer Service at 1-800-323-8029 to complete the field correction.

Device

Device Recall Gendex eXpert DC Intraoral XRay System
  • Model / Serial
    Model 110-0205G1, catalog number EXPERTDC75NA; serial numbers 1987591 - 09/2010, 1987597 - 09/2010, 1987598 - 09/2010, 1987599 - 09/2010 and 1987600 - 09/2010
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    California
  • Product Description
    Gendex Dental Systems, Gendex eXpert DC Intraoral X-Ray System; a dental x-ray system; Model 110-0205G1, catalog number EXPERTDC75NA
  • Manufacturer
    Gendex Dental Systems

Manufacturer

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