Z-0842-06

Candela Laser VBeam Perfecta, a Pulsed Dye Laser used for General Surgery, Dermatology, Gynecology, Podiatry...

Name: Z-0842-06 Candela Laser VBeam Perfecta, a Pulsed Dye Laser used for General Surgery, Dermatology, Gynecology, Podiatry...
Creator: Candela Laser Corporation
Published: 2006-01-17
License: https://open.fda.gov/license/

Candela Corporation / initiated 2006-01-17 / Terminated

FDA source

Candela Laser Corporation began a recall of Candela Laser VBeam Perfecta, a Pulsed Dye Laser used for General Surgery, Dermatology, Gynecology, Podiatry. Model Number: 9914-00-0300 on 2006-01-17. The reason FDA records is "Handle fires even when the finger is off the switch". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0842-06
Status: Terminated
Initiated: 2006-01-17
Posted: 2006-05-04
Terminated: 2006-05-04
Recalling firm: Candela Corporation
Product: Candela Laser VBeam Perfecta, a Pulsed Dye Laser used for General Surgery, Dermatology, Gynecology, Podiatry. Model Number: 9914-00-0300
Product code: GXE Leukotome
Reason for recall: Handle fires even when the finger is off the switch
FDA 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 in commerce: 59 units
Distribution: Nationwide Foreign: Canada, Spain, Japan, Germany, France, Switzerland
Product codes and lots: Serial Number: SN 9998; 9914-0300-0001 through 9914-0300-0058

Product code GXE

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)