Z-1646-2008

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

Name: Z-1646-2008 i-CAT 17-19 Cone Beam 3D Dental Imaging System. This product is also sold under a private label as KaVo 3D...
Creator: Imaging Sciences Intl Inc
Published: 2008-03-19
License: https://open.fda.gov/license/

Dental Imaging Technologies Corporation / initiated 2008-03-19 / Terminated / root cause: labeling and UDI

FDA source

Imaging Sciences Intl Inc began a recall of i-CAT 17-19 Cone Beam 3D Dental Imaging System. This product is also sold under a private label as KaVo 3D eXam on 2008-03-19. The reason FDA records is "Incorrect scatter information in the manual". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1646-2008
Status: Terminated
Initiated: 2008-03-19
Posted: 2008-09-01
Terminated: 2009-05-05
Recalling firm: Dental Imaging Technologies Corporation
Product: i-CAT 17-19 Cone Beam 3D Dental Imaging System. This product is also sold under a private label as KaVo 3D eXam
Product code: MUH System, X-Ray, Extraoral Source, Digital
Reason for recall: Incorrect scatter information in the manual.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
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.
Quantity in commerce: 1203 units
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 codes and lots: Part number 1-10-1-0. The KaVo part number is K1-10-3-0

Product code MUH

K061284Class III-Cat ScannerImaging Sciences Intl., Inc. / cleared 2006-07-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)