Recall Z-0508-2007 ยท GEX Powered Laser Surgical Instrument
Candela Laser Corporation
Candela Corporation Vbeam Aesthetica Laser System, Model/Catalog # 9914-00-0320 Vbeam Aesthetica w/ gray enclosure and rose colored display
| Date | Feb 15, 2007 (initiated Jan 15, 2007) |
| Status | Terminated |
| Reason | Internal component may overheat causing the possibility of risk of fire or smoke |
| Root cause | Other |
| Action | Candela Corporation notified US consignees by letter (w/return receipt) identifying the potential problem on 1/17/2007. Candela services will contact the customers and schedule upgrades. International packages were sent to each distributor via Fed-x/DHL tracking on 1/17/2007. Distributors were asked to forward individual serial number packages to their customers. Upgrade material will be forwarded to distributors upon which they will schedule upgrades with their customers. |
| Quantity | 474 laser systems total (all models) |
| Distribution | Worldwide including USA, Europe, Far East, Canada, Japan, Australia, Middle East, Mexico |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050673 | CANDELA FAMILY OF PULSE DYE LASER SYSTEMS Candela Corp., Jun 13, 2005 |