Imaging Sciences Intl Inc i-CAT 17-19 Cone Beam 3D Dental Imaging System. This product is also sold under a private label as KaVo 3D eXam Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
i-CAT 17-19 Cone Beam 3D Dental Imaging System. This product is also sold under a private label as KaVo 3D eXam
Brand
Imaging Sciences Intl Inc
Lot Codes / Batch Numbers
Part number 1-10-1-0. The KaVo part number is K1-10-3-0
Products Sold
Part number 1-10-1-0. The KaVo part number is K1-10-3-0
Imaging Sciences Intl Inc is recalling i-CAT 17-19 Cone Beam 3D Dental Imaging System. This product is also sold under a private label as K due to Incorrect scatter information in the manual.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Incorrect scatter information in the manual.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026