Candela Corporation Vbeam Platinum Laser System, Model/Catalog # 9914-00-0310 Vbeam Platinum w/ rose gray enclosure and
FDA device recall Z-0510-2007 · posted 2007-02-15 · Terminated
Recall details
- Recalling firm
- Candela Laser Corporation
- Reason for recall
- Internal component may overheat causing the possibility of risk of fire or smoke
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- GEX
- Quantity affected
- 474 laser systems total (all models)
- Distribution
- Worldwide including USA, Europe, Far East, Canada, Japan, Australia, Middle East, Mexico
- Date initiated
- 2007-01-15
- Date posted
- 2007-02-15
- Date terminated
- 2014-02-03
- Location
- Wayland, MA
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