Z-0291-04

Candela Smoothbeam Laser System Model Numbers: 9914-00-0820 9914-06-0820 9914-07-0820 9914-08-0820...

Name: Z-0291-04 Candela Smoothbeam Laser System Model Numbers: 9914-00-0820 9914-06-0820 9914-07-0820 9914-08-0820...
Creator: Candela Laser Corporation
Published: 2003-11-25
License: https://open.fda.gov/license/

Candela Corporation / initiated 2003-11-25 / Terminated

FDA source

Candela Laser Corporation began a recall of Candela Smoothbeam Laser System Model Numbers: 9914-00-0820 9914-06-0820 9914-07-0820 9914-08-0820 9914-10-0820 Units are the same except for color on 2003-11-25. The reason FDA records is "Laser may pulse and not dispense cryogen resulting in patient injury". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0291-04
Status: Terminated
Initiated: 2003-11-25
Posted: 2004-01-01
Terminated: 2006-12-06
Recalling firm: Candela Corporation
Product: Candela Smoothbeam Laser System Model Numbers: 9914-00-0820 9914-06-0820 9914-07-0820 9914-08-0820 9914-10-0820 Units are the same except for color
Product code: GEX Powered Laser Surgical Instrument
Reason for recall: Laser may pulse and not dispense cryogen resulting in patient injury
FDA root cause: Other
Action: 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.
Quantity in commerce: 506 units
Distribution: Nationwide Foreign: Canada,Thailand, Germany, Spain , Japan, Italy, Greece, Saudi Arabia, UK, France, Switzerland, Mexico, Ukraine, Kuwait, Netherlands.
Product codes and lots: Serial Numbers: 9914-0820-0101 thru 9914-0820-0602 9914-0820-P2 9914-0820-P4 9914-0820-P5 9914-0820-P6

Product code GEX

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)