Z-0511-2007

Candela Corporation Vbeam Platinum Laser System, Model/Catalog # 9914-08-0310 Vbeam Platinum w/ gray...

Name: Z-0511-2007 Candela Corporation Vbeam Platinum Laser System, Model/Catalog # 9914-08-0310 Vbeam Platinum w/ gray...
Creator: Candela Laser Corporation
Published: 2007-01-15
License: https://open.fda.gov/license/

Candela Corporation / initiated 2007-01-15 / Terminated

FDA source

Candela Laser Corporation began a recall of Candela Corporation Vbeam Platinum Laser System, Model/Catalog # 9914-08-0310 Vbeam Platinum w/ gray enclosure and gray colored display on 2007-01-15. The reason FDA records is "Internal component may overheat causing the possibility of risk of fire or smoke". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0511-2007
Status: Terminated
Initiated: 2007-01-15
Posted: 2007-02-15
Terminated: 2014-02-03
Recalling firm: Candela Corporation
Product: Candela Corporation Vbeam Platinum Laser System, Model/Catalog # 9914-08-0310 Vbeam Platinum w/ gray enclosure and gray colored display
Product code: GEX Powered Laser Surgical Instrument
Reason for recall: Internal component may overheat causing the possibility of risk of fire or smoke
FDA 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 in commerce: 474 laser systems total (all models)
Distribution: Worldwide including USA, Europe, Far East, Canada, Japan, Australia, Middle East, Mexico
Product codes and lots: 9914-0310-XXXXX, where XXXX = 0001 thru 0513 (a sequential # independent of it being a Perfecta, Platinum, or Aesthetica model)

Product code GEX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)