Events

Recall of I-CAT 3D DENTAL IMAGING SYSTEM - MAIN UNIT

According to Health Canada (via FOI), this recall involved a device in Canada 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
    68604
  • Event Risk Class
    II
  • Event Initiated Date
    2009-10-30
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Fault in the brake system may result in granty-overhead dropping quickly when the overhead is lowered. i-cat classic containing electrical brake.

Device

I-CAT 3D DENTAL IMAGING SYSTEM - MAIN UNIT
  • Model / Serial
    Model Catalog: 9140-0000-0000 (Lot serial: ICU070519); Model Catalog: 9140-0000-0000 (Lot serial: ICU070518); Model Catalog: 9140-0000-0000 (Lot serial: ICU070488)
  • Product Description
    I-CAT 3D DENTAL IMAGING SYSTEM
  • Manufacturer
    IMAGING SCIENCES INTERNATIONAL LLC

Manufacturer

IMAGING SCIENCES INTERNATIONAL LLC