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U.S. Department of Health and Human Services

Class 2 Device Recall Candela Corporation Vbeam Aesthetica Laser System

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 Class 2 Recall
Candela Corporation Vbeam Aesthetica Laser System
see related information
Date Posted February 15, 2007
Recall Status1 Terminated on May 01, 2007
Recall Number Z-0510-2007
Recall Event ID 37180
Premarket Notification
510(K) Number
Product Classification Powered Laser Surgical Instrument - Product Code GEX
Product Candela Corporation Vbeam Platinum Laser System, Model/Catalog # 9914-00-0310 Vbeam Platinum w/ rose gray enclosure and rose colored display
Code Information 9914-0310-XXXXX, where XXXX = 0001 thru 0513 (a sequential # independent of it being a Perfecta, Platinum, or Aesthetica model)
Recalling Firm/
Candela Laser Corporation
530 Boston Post Rd
Wayland, Massachusetts 01778-1833
For Additional Information Contact Ed Gramer
Manufacturer Reason
for Recall
Internal component may overheat causing the possibility of risk of fire or smoke
FDA Determined
Cause 2
DESIGN: Software Design
Action Candela Corporation notified US consignees by letter (w/return receipt) identifying the potential problem on 1/17/2007. Candela services will contact the customers and schedule upgrades. International packages were sent to each distributor via Fed-x/DHL tracking on 1/17/2007. Distributors were asked to forward individual serial number packages to their customers. Upgrade material will be forwarded to distributors upon which they will schedule upgrades with their customers.
Quantity in Commerce 474 laser systems total (all models)
Distribution Worldwide including USA, Europe, Far East, Canada, Japan, Australia, Middle East, Mexico
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = GEX and Original Applicant = CANDELA CORP.