Recall Z-1646-2008
Imaging Sciences Intl Inc · initiated March 19, 2008
Product
i-CAT 17-19 Cone Beam 3D Dental Imaging System. This product is also sold under a private label as KaVo 3D eXam
Codes / lots: Part number 1-10-1-0. The KaVo part number is K1-10-3-0
Reason for recall
Incorrect scatter information in the manual.
FDA-determined cause: Error in labeling
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.
Details
- Recall number
- Z-1646-2008
- Initiated
- March 19, 2008
- Posted by FDA
- September 1, 2008
- Terminated
- May 5, 2009
- Product code
- MUH – System, X-Ray, Extraoral Source, Digital
- 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, Turkey, United Kingdom, Australia, New Zealand, Chile, Israel, South Korea, UAE, India, Argentina…
- Recalling firm
- Imaging Sciences Intl Inc, Hatfield, PA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1645-2008 | i-CAT Classic 3D Dental Imaging Systemincorrect scatter labeling | 03/19/2008Terminated |