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U.S. Department of Health and Human Services

Class 2 Device Recall QPlus T Powered Laser Surgical Instrument

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 Class 2 Recall
QPlus T Powered Laser Surgical Instrument
see related information
Date Posted January 17, 2013
Recall Status1 Terminated on January 23, 2013
Recall Number Z-0691-2013
Recall Event ID 64039
Premarket Notification
510(K) Numbers
K073549  K123168 
Product Classification Powered Laser Surgical Instrument - Product Code GEX
Product Q-Plus T Powered Laser Surgical Instrument Nd:YAG 1064 nm and 532 nm: Treatment of vascular lesions and pigmented lesions; Hair and tattoo removal; The incision, excision, ablation, vaporization of soft tissue for general dermatology. Ruby 694nm: Cutting, vaporization and ablation of soft tissue; Tattoo removal; Treatment of benign pigmented lesions.
Code Information All codes and devices are applicable.
Recalling Firm/
Manufacturer
Quanta System, S.p.A.
Via IV Novembre, 116
Solbiate Olona (VA)
Consumer Instructions Contact the recalling firm for information
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 2
MISBRANDING: 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 75 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 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 = QUANTA SYSTEM SPA
510(K)s with Product Code = GEX and Original Applicant = QUANTA SYSTEM, S.P.A.
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