i-CAT 17-19 Cone Beam 3D Dental Imaging System. This product is also sold under a private label as KaVo 3D eXam
FDA device recall Z-1646-2008 · posted 2008-09-01 · Terminated
Recall details
- Recalling firm
- Imaging Sciences Intl Inc
- Reason for recall
- Incorrect scatter information in the manual.
- Action taken
- 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
- Status
- Terminated
- Product code
- MUH
- Quantity affected
- 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
- Date initiated
- 2008-03-19
- Date posted
- 2008-09-01
- Date terminated
- 2009-05-05
- Location
- Hatfield, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| I-CAT SCANNER (K061284) | Imaging Sciences Intl., Inc. | 2006-07-03 |