Date Initiated by Firm | January 15, 2007 |
Date Posted | February 15, 2007 |
Recall Status1 |
Terminated 3 on February 03, 2014 |
Recall Number | Z-0511-2007 |
Recall Event ID |
37180 |
Product Classification |
Laser System - Product Code GEX
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Product | Candela Corporation Vbeam Platinum Laser System, Model/Catalog # 9914-08-0310 Vbeam Platinum w/ gray enclosure and gray 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/ Manufacturer |
Candela Laser Corporation 530 Boston Post Rd Wayland MA 01778-1833
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For Additional Information Contact | Ed Gramer 508-358-7637 |
Manufacturer Reason for Recall | Internal component may overheat causing the possibility of risk of fire or smoke |
FDA Determined Cause 2 | Other |
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 |
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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.
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