Recall Z-1646-2008 ยท MUH System, X-Ray, Extraoral Source, Digital
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
| Date | Sep 1, 2008 (initiated Mar 19, 2008) |
| Status | Terminated |
| Reason | Incorrect scatter information in the manual. |
| 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 | 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, Turk |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061284 | I-CAT SCANNER Imaging Sciences Intl., Inc., Jul 3, 2006 |