Events

Recall of Device Recall iCAT 1719 Cone Beam 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 Intl Inc.

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
    47535
  • Event Risk Class
    Class 2
  • Event Number
    Z-1646-2008
  • Event Initiated Date
    2008-03-19
  • Event Date Posted
    2008-09-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-05-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=69716
  • 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
    Incorrect scatter information in the manual.
  • Action
    Firm issued Urgent Medical Device Recall letters dated 3/19/08 to their customers. The distributors were provided background information and specific instruction on the steps to perform to correct the problem. If you have questions or have not received this letter, contact Francine McCoonse at 215-997-5666 ext 1340.

Device

Device Recall iCAT 1719 Cone Beam 3D Dental Imaging System
  • Model / Serial
    Part number 1-10-1-0. The KaVo part number is K1-10-3-0
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The products were shipped to distributors and dental offices nationwide. The products were also shipped to Canada, Austria, Belgium, Czech Republic, England, Finland, France, Germany, Hungary, Ireland, Italy, Latvia, Lithuania, Netherlands, Norway, Portugal, Lavenia, Spain, Sweden, Switzerland, Turkey, United Kingdom, Australia, New Zealand, Chile, Israel, South Korea, UAE, India, Argentina, Brazil, China, Columbia, Hong Kong, Jamaica, Korea, Lebanon, Malaysia, Morocco, Russia, Scotland, Taiwan, Thailand, and Singapore.
  • Product Description
    i-CAT 17-19 Cone Beam 3D Dental Imaging System. This product is also sold under a private label as KaVo 3D eXam
  • Manufacturer
    Imaging Sciences Intl Inc

Manufacturer

Imaging Sciences Intl Inc
  • Manufacturer Address
    Imaging Sciences Intl Inc, 1910 N Penn Rd, Hatfield PA 19440-1960
  • Source
    USFDA