Recall Z-0050-2014 ยท GEX Powered Laser Surgical Instrument
Convergent Dental
Solea 1.0 Laser Surgical instrument for use in general and plastic surgery and dermatology.
| Date | Oct 22, 2013 (initiated Sep 12, 2013) |
| Status | Terminated |
| Reason | Specific error condition could lead to unintended laser emission during laser activation. |
| Root cause | Software design |
| Action | The following Notice of Correction letter was sent out to all customers via email on 9/12/13, and followed up with a direct phone call to confirm receipt and review the contents of the letter: Dear Dr. [Customer name], This email is to inform you of a pending notice of correction regarding your Solea system, serial #[Customer serial number]. We have identified a specific error condition that could lead to unintended laser emission during laser activation. The software defect that caused the error condition has been identified and tested. Please do not use your Solea system until further n |
| Quantity | 5 |
| Distribution | US distribution including states of: MA, CT, NY. |
| FDA record | Open on fda.gov |