Recall Z-1265-2009 ยท MUH System, X-Ray, Extraoral Source, Digital
Imaging Sciences International, LLC
Gendex CB-500, 3D Dental Imaging Systems, Model Number G1-15-1-0. This product is manufactured by Imaging Sciences International for Gendex Corporation.
| Date | May 22, 2009 (initiated Jan 8, 2009) |
| Status | Terminated |
| Reason | faulty calibration |
| Root cause | Nonconforming Material/Component |
| Action | Imaging Sciences International issued a letter to Customers dated January 7, 2009 informing them of the affected device. Users were advised to discontinue use of the device until they are contacted by a service representative and a certified re-calibration of the device is performed. Users were also asked to return a completed "Acknowledgement Form" by fax to the firm at 1-215-997-5665. Additional questions can be made to Imaging Sciences International by calling 1-800-205-3570 Extension 299. |
| Quantity | 24 units |
| Distribution | Worldwide Distribution -- US to states of FL, OH and PA and countries of Canada, Germany, England, Italy and Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061284 | I-CAT SCANNER Imaging Sciences Intl., Inc., Jul 3, 2006 |