Class 2 Device Recall

• Date Initiated by Firm: January 17, 2006
• Date Posted: May 04, 2006
• Recall Status: Terminated 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/ Manufacturer: Candela Laser Corporation; 530 Boston Post Rd; Wayland MA 01778-1833
• For Additional Information Contact: Edward Gramer; 508-358-7637
• Manufacturer Reason for Recall: Handle fires even when the finger is off the switch
• FDA Determined 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
• 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