FDA Medical Device Recalls (openFDA)
Candela Laser Corporation: Candela Corporation Vbeam Platinum Laser System, Model/Catalog # 9914-00-0310 Vbeam Platinum w/ rose gray enclosure and rose colored display
- Recall number
- Z-0510-2007
- Recalling firm
- Candela Laser Corporation
- Product
- Candela Corporation Vbeam Platinum Laser System, Model/Catalog # 9914-00-0310 Vbeam Platinum w/ rose gray enclosure and rose colored display
- Status
- Terminated
- Initiated
- 2007-01-15
- Posted
- 2007-02-15
- Terminated
- 2014-02-03
- 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
- Lot, serial or model codes
- 9914-0310-XXXXX, where XXXX = 0001 thru 0513 (a sequential # independent of it being a Perfecta, Platinum, or Aesthetica model)
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GEX
- Firm FEI
- 1218402
- Firm city
- Wayland
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28