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Terminated

Candela Laser VBeam Perfecta, a Pulsed Dye Laser used for General Surgery, Dermatology, Gynecology, Podiatry. Model Number: 9914-00-0300

FDA Recall Z-0842-06 · Posted 2006-05-04

Recalling FirmCandela Laser Corporation
Recall StatusTerminated
Product CodeGXE
Date Initiated2006-01-17
Date Terminated2006-05-04
Product Quantity59 units

Reason for Recall

Handle fires even when the finger is off the switch

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide Foreign: Canada, Spain, Japan, Germany, France, Switzerland

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K051359CANDELA FAMILY OF PULSED DYE LASER SYSTEMS: PIGMENTED LESION HANDPIECE ACCESSORYCandela Corp. · 2005-07-13K050673CANDELA FAMILY OF PULSE DYE LASER SYSTEMSCandela Corp. · 2005-06-13

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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