Events

Recall of eXpertDC intraoral xray

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

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
    69064
  • Event Risk Class
    Class 2
  • Event Number
    Z-0009-2015
  • Event Initiated Date
    2014-08-12
  • Event Date Posted
    2014-10-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-03-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129485
  • 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
    Two (2) failures of the spring link components within the articulated arm assembly. the spring links broke during normal assembly process for the articulated arm during first cycle of the arm, prior to the 14lb tube head (full load) being installed onto the assembled articulated arm.
  • Action
    Gendex sent a Recall Notification Letter, dated August 12, 2014 and a second Communication Notification letter on September 22, 2014 to all affected customers. The letter identified the affected product, problem, and actions to be taken. For questions contact Gendex Customer Service at 1-800-323-8029.

Device

eXpertDC intraoral xray
  • Model / Serial
    Models: eXpert DC, NA, 75 Inch reach; eXpert DC, NA, 65 Inch reach; eXpert DC, CN, 55 Inch reach; eXpert DC, WW, 75 Inch reach; eXpert DC, WW, 65 Inch reach; eXpert DC, WW, 55 Inch reach; OEM Arm Assembly w/o cables; Assy, Articulated Arm & Tubehead, eDC; and Assy, Articulated Arm & Tubehead, 765DC; with multiple part numbers and serial numbers: see distribution list for these details.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide and the countries of Europe, Canada, Australia, China, Russia, Taiwan, Singapore, and Thailand.
  • Product Description
    eXpertDC intraoral x-ray, models: eXpert DC, NA, 75 Inch reach; eXpert DC, NA, 65 Inch reach; eXpert DC, CN, 55 Inch reach; eXpert DC, WW, 75 Inch reach; eXpert DC, WW, 65 Inch reach; eXpert DC, WW, 55 Inch reach; OEM Arm Assembly || w/o cables; Assy, Articulated Arm & Tubehead, eDC; and Assy, Articulated Arm || & Tubehead, 765DC || Product Usage: intraoral x-ray
  • Manufacturer
    Gendex Corp

Manufacturer

Gendex Corp
  • Manufacturer Address
    Gendex Corp, 2800 Crystal Dr, Hatfield PA 19440-1944
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Source
    USFDA