Events

Recall of iCat Classic, 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
    53771
  • Event Risk Class
    Class 2
  • Event Number
    Z-0543-2010
  • Event Initiated Date
    2009-10-30
  • Event Date Posted
    2009-12-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-09-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86546
  • 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, tomography, computed - Product Code JAK
  • Reason
    Overhead carriage drops quickly.
  • Action
    Imaging Sciences International issued an "Urgent Medical Device Recall" notification dated October 30, 2009 to all customers informing them of the problem and that a field service representative would schedule a visit to install an upgrade kit. For further information, contact Imaging Sciences International at 1-800-205-3570, option 5.

Device

iCat Classic, 3D Dental Imaging System
  • Model / Serial
    Serial Numbers: ICU070427, ICU070428, ICU070429, ICU070430, ICU070432, ICU070433, ICU070434, ICU070435, ICU070436, ICU070437, ICU070438, ICU070439, ICU070440, ICU070441, ICU070442, ICU070443, ICU070445, ICU070446, ICU070447, ICU070448, ICU070449, ICU070451, ICU070452, ICU070453, ICU070454, ICU070455, ICU070456, ICU070457, ICU070458, ICU070459, ICU070460, ICU070461, ICU070462, ICU070463, ICU070464, ICU070465, ICU070466, ICU070467, ICU070468, ICU070469, ICU070470, ICU070471, ICU070472, ICU070473, ICU070474, ICU070475, ICU070476, ICU070477, ICU070478, ICU070479, ICU070480, ICU070481, ICU070482, ICU070483, ICU070484, ICU070485, ICU070486, ICU070487, ICU070488, ICU070489, ICU070490, ICU070491, ICU070492, ICU070493, ICU070494, ICU070495, ICU070497, ICU070498, ICU070499, ICU070500, ICU070501, ICU070502, ICU070503, ICU070505, ICU070506, ICU070507, ICU070508, ICU070509, ICU070510, ICU070512, ICU070513, ICU070514, ICU070515, ICU070516, ICU070517, ICU070518, ICU070519, ICU070520, ICU070521, ICU070522, ICU070523, ICU070524, ICU070525, ICU070527, ICU070528, ICU070529, ICU070530, ICU070531 and ICU070532.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- Including the United States, Austria, Australia, Belgium, Brazil, Canada, France, Germany, India, Israel, Italy, Jamaica, Spain, South Korea and Taiwan.
  • Product Description
    i-Cat Classic, 3D Dental Imaging System manufactured by Imaging Sciences International, Hatfield, PA. || To be used whenever a dentis, oral surgeon or other physician needs 3D information of high contrast objects.
  • 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