Recall Z-0291-04 ยท GEX Powered Laser Surgical Instrument
Candela Laser Corporation
Candela Smoothbeam Laser System Model Numbers: 9914-00-0820 9914-06-0820 9914-07-0820 9914-08-0820 9914-10-0820 Units are the same except for color
| Date | Jan 1, 2004 (initiated Nov 25, 2003) |
| Status | Terminated |
| Reason | Laser may pulse and not dispense cryogen resulting in patient injury |
| Root cause | Other |
| Action | Candela notified direct customers and distributors by letter dated 11125/03 and issued Certified Mail. Accounts are requested to perform two tests on the unit to determine if the unit has the problem. If a unit fails, Candela's Field Service will make the repair. Distributors are requested to notify their customers. |
| Quantity | 506 units |
| Distribution | Nationwide Foreign: Canada,Thailand, Germany, Spain , Japan, Italy, Greece, Saudi Arabia, UK, France, Switzerland, Mexico, Ukraine, Kuwait, Netherlands. |
| FDA record | Open on fda.gov |