FDA Medical Device Recalls (openFDA)
Candela Laser Corporation: 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
- Recall number
- Z-0291-04
- Recalling firm
- Candela Laser 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
- Status
- Terminated
- Initiated
- 2003-11-25
- Posted
- 2004-01-01
- Terminated
- 2006-12-06
- Reason
- Laser may pulse and not dispense cryogen resulting in patient injury
- 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
- 506 units
- Distribution
- Nationwide Foreign: Canada,Thailand, Germany, Spain , Japan, Italy, Greece, Saudi Arabia, UK, France, Switzerland, Mexico, Ukraine, Kuwait, Netherlands.
- Lot, serial or model codes
- Serial Numbers: 9914-0820-0101 thru 9914-0820-0602 9914-0820-P2 9914-0820-P4 9914-0820-P5 9914-0820-P6
- 510(k) numbers
- ["K022884","K013825","K030834","K030846"]
- 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