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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm January 17, 2006
Date Posted May 04, 2006
Recall Status1 Terminated 3 on May 04, 2006
Recall Number Z-0842-06
Recall Event ID 35221
510(K)Number K050673  k051359  
Product Classification Leukotome - Product Code GXE
Product Candela Laser VBeam Perfecta, a Pulsed Dye Laser used for General Surgery, Dermatology, Gynecology, Podiatry.
Model Number: 9914-00-0300
Code Information Serial Number: SN 9998;  9914-0300-0001 through 9914-0300-0058
Recalling Firm/
Candela Laser Corporation
530 Boston Post Rd
Wayland MA 01778-1833
For Additional Information Contact Edward Gramer
Manufacturer Reason
for Recall
Handle fires even when the finger is off the switch
FDA Determined
Cause 2
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
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GXE and Original Applicant = CANDELA CORP.