Events

Recall of Device Recall Gendex eXpert DC Intraoral Dental 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
    61295
  • Event Risk Class
    Class 2
  • Event Number
    Z-1358-2012
  • Event Initiated Date
    2011-12-29
  • Event Date Posted
    2012-04-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-06-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107747
  • 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
    Improper hardware was used during installation of the expert dc intraoral x-ray system units causing drifting of the tubehead assembly.
  • Action
    Gendex Dental Systems sent a Urgent Medical Device Correction letter dated December 29, 2011, to both affected customers. The Customers were provided background information and details on how the nonconforming installations of the devices would be corrected. Gendex Dental Systems apologizes for any inconvenience caused by this issue, and request your corporation as we correct this problem. The customers were instructed to complete and return the Acknowledgement Form upon receipt of the recall notification letter and fax to (215) 997-5665. For further questions please call (215) 954-0365.

Device

Device Recall Gendex eXpert DC Intraoral Dental XRay System
  • Model / Serial
    Model # EXPERTDC75NA, serial numbers 2007017, 2006983, 2007018, 2006982, 2003916, 2007015, 2007051, 2007021, 2006975, 2003900, 2006987, 2007027, 2006989, 2003812, 2007024, 2006985, 2006986, 2006980, 2007025, 2007026, 2006979, 2006976, 2003840, 2003906, 2003820, 2006977, 2007023, 2006978, 2003917, 2003907, 2003904, 2007028, 2007022, 2007019, 2003829, 2003876, 2003909, 2003920, 2003862, 2007029, 2007016, 2003937, 2003877, 2007020, 2003835, 2003908; model # EXPERTDC55NA, serial numbers 2004394, 2004396, 2004437, 2004430, 2004436, 2004416
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    USA including the states of Iowa and Illinois.
  • Product Description
    Gendex eXpert DC Intraoral Dental X-Ray System || Device is to be used as an extra-oral source of X-Rays in Dental Radiography
  • Manufacturer
    Gendex Dental Systems

Manufacturer

Gendex Dental Systems
  • Manufacturer Address
    Gendex Dental Systems, 1910 N Penn Rd, Hatfield PA 19440-1959
  • Source
    USFDA