Class 2 Device Recall Eterna Giovinezza System

• Date Initiated by Firm: November 07, 2012
• Date Posted: January 17, 2013
• Recall Status: Terminated on January 23, 2013
• Recall Number: Z-0692-2013
• Recall Event ID: 64039
• 510(K)Number: K051113
• Product Classification: Powered laser surgical instrument - Product Code GEX
• Product: Eterna Giovinezza System, Powered Laser Surgical Instrument. Permanent hair reduction; Photocoagulation of dermatological vascular lesions; Photothermolysis of blood vessels (treatment of facial and leg veins); Treatment of benign pigmented lesions; Inflammatory acne
• Code Information: All codes and devices are applicable.
• Recalling Firm/ Manufacturer: Quanta System, S.p.A.; Via IV Novembre, 116; Solbiate Olona (VA) Italy
• Manufacturer Reason for Recall: Quanta System S.p.A, Italy, is notifying U.S. consignees that their website contained promotional materials for products distributed in the U.S. which did not specify that some of the claims made therein were not meant to apply to the U.S. distributed devices.
• FDA Determined Cause: Labeling False and Misleading
• Action: Quanta System sent a letter dated November 7, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to perform the following: quarantine and destroy all promotional literature printed from the manufacturer, website or obtained from the manufacturer. Provide any promotional literature independently produced by the initial importer or distributor containing information about Quanta System products. Provide URL of initial importers or distributors website if information about Quanta System products is contained therein. Provide a written certification that all actions have been taken. Quanta System has or will: review all promotional materials and website information provided by initial importers and distributors; advise initial importers and distributors of any actions that need to be taken to change promotional materials and/or website information. For questions regarding this recall call 303-223-4336.
• Quantity in Commerce: 12 units
• Distribution: Class II Recall - Worldwide Distribution - USA including TX, AZ, OR, and CO. Only US product is affected by this recall.
• 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 = GEX