Terminated

i-CAT 17-19 Cone Beam 3D Dental Imaging System. This product is also sold under a private label as KaVo 3D eXam

FDA Recall Z-1646-2008 · Posted 2008-09-01

Recalling FirmImaging Sciences Intl Inc

Recall StatusTerminated

Product CodeMUH

Date Initiated2008-03-19

Date Terminated2009-05-05

Product Quantity1203 units

Reason for Recall

Incorrect scatter information in the manual.

Firm 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.

Root Cause

Error in labeling

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K061284I-CAT SCANNERImaging Sciences Intl., Inc. · 2006-07-03

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.