Gendex CB-500, 3D Dental Imaging Systems, Model Number G1-15-1-0. This product is manufactured by Imaging Sciences Inter
FDA device recall Z-1265-2009 · posted 2009-05-22 · Terminated
Recall details
- Recalling firm
- Imaging Sciences International, LLC
- Reason for recall
- faulty calibration
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- MUH
- Quantity affected
- 24 units
- Distribution
- Worldwide Distribution -- US to states of FL, OH and PA and countries of Canada, Germany, England, Italy and Switzerland.
- Date initiated
- 2009-01-08
- Date posted
- 2009-05-22
- Date terminated
- 2009-06-04
- 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 |