Recall Z-0543-2010 ยท JAK System, X-Ray, Tomography, Computed
Imaging Sciences International, LLC
i-Cat Classic, 3D Dental Imaging System manufactured by Imaging Sciences International, Hatfield, PA. To be used whenever a dentis, oral surgeon or other physician needs 3D information of high contrast objects.
| Date | Dec 17, 2009 (initiated Oct 30, 2009) |
| Status | Terminated |
| Reason | overhead carriage drops quickly |
| Root cause | Device Design |
| Action | Imaging Sciences International issued an "Urgent Medical Device Recall" notification dated October 30, 2009 to all customers informing them of the problem and that a field service representative would schedule a visit to install an upgrade kit. For further information, contact Imaging Sciences International at 1-800-205-3570, option 5. |
| Quantity | 98 units |
| Distribution | Worldwide Distribution -- Including the United States, Austria, Australia, Belgium, Brazil, Canada, France, Germany, India, Israel, Italy, Jamaica, Spain, South Korea and Taiwan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051980 | DVT SCANNER Imaging Sciences Intl., Inc., Aug 19, 2005 |