FDA Medical Device Recalls (openFDA)
Candela Laser Corporation: Candela Laser VBeam Perfecta, a Pulsed Dye Laser used for General Surgery, Dermatology, Gynecology, Podiatry. Model Number: 9914-00-0300
- Recall number
- Z-0842-06
- Recalling firm
- Candela Laser Corporation
- Product
- Candela Laser VBeam Perfecta, a Pulsed Dye Laser used for General Surgery, Dermatology, Gynecology, Podiatry. Model Number: 9914-00-0300
- Status
- Terminated
- Initiated
- 2006-01-17
- Posted
- 2006-05-04
- Terminated
- 2006-05-04
- Reason
- Handle fires even when the finger is off the switch
- Root cause
- Other
- Action
- Candela notified Service Representaives by email on 1/17/06 providing Technical Service Bulletin, listing of laser systems to be reworked and script to address customer questions during visit to correct system.
- Quantity
- 59 units
- Distribution
- Nationwide Foreign: Canada, Spain, Japan, Germany, France, Switzerland
- Lot, serial or model codes
- Serial Number: SN 9998; 9914-0300-0001 through 9914-0300-0058
- 510(k) numbers
- ["K050673","K051359"]
- PMA numbers
- not on file
- Product code
- GXE
- 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