Events

Recall of Device Recall Gendex CB500 3D Dental Imaging System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Imaging Sciences International, 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
    51424
  • Event Risk Class
    Class 2
  • Event Number
    Z-1265-2009
  • Event Initiated Date
    2009-01-08
  • Event Date Posted
    2009-05-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-06-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=80255
  • 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
    System,x-ray,extraoral source,digital - Product Code MUH
  • Reason
    Faulty calibration.
  • Action
    Imaging Sciences International issued a letter to Customers dated January 7, 2009 informing them of the affected device. Users were advised to discontinue use of the device until they are contacted by a service representative and a certified re-calibration of the device is performed. Users were also asked to return a completed "Acknowledgement Form" by fax to the firm at 1-215-997-5665. Additional questions can be made to Imaging Sciences International by calling 1-800-205-3570 Extension 299.

Device

Device Recall Gendex CB500 3D Dental Imaging System
  • Model / Serial
    Model number: G1-15-1-0; Serial Numbers: NU010261, NU010340, NU010224, NU010286, NU010265, NU010267, NU010282, NU010283, NU010284, NU010287, NU010288, NU010289, NU010292, NU010293, NU010294, NU010299, NU010303, NU010310, NU010315, NU010316, NU010317, NU010326, NU010290, and NU010291.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- US to states of FL, OH and PA and countries of Canada, Germany, England, Italy and Switzerland.
  • Product Description
    Gendex CB-500, 3D Dental Imaging Systems, Model Number G1-15-1-0. This product is manufactured by Imaging Sciences International for Gendex Corporation.
  • Manufacturer
    Imaging Sciences International, LLC

Manufacturer

Imaging Sciences International, LLC
  • Manufacturer Address
    Imaging Sciences International, LLC, 1910 North Penn Rd, Hatfield PA 19440-1960
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Source
    USFDA