Candela Smoothbeam Laser System Model Numbers: 9914-00-0820 9914-06-0820 9914-07-0820 9914-08-0820 9914-10-0820 Units ar
FDA device recall Z-0291-04 · posted 2004-01-01 · Terminated
Recall details
- Recalling firm
- Candela Laser Corporation
- Reason for recall
- Laser may pulse and not dispense cryogen resulting in patient injury
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- GEX
- Quantity affected
- 506 units
- Distribution
- Nationwide Foreign: Canada,Thailand, Germany, Spain , Japan, Italy, Greece, Saudi Arabia, UK, France, Switzerland, Mexico, Ukraine, Kuwait, Netherlands.
- Date initiated
- 2003-11-25
- Date posted
- 2004-01-01
- Date terminated
- 2006-12-06
- Location
- Wayland, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CANDELA SMOOTHBEAM LASER SYSTEM (K030834) | Candela Corp. | 2003-12-03 |
| CANDELA SMOOTHBEAM LASER SYSTEM (K030846) | Candela Corp. | 2003-09-16 |
| CANDELA SMOOTHBEAM LASER SYSTEM (K022884) | Candela Corp. | 2003-01-22 |
| CANDELA SMOOTHBEAM LASER SYSTEM (K013825) | Candela Corp. | 2002-02-15 |