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U.S. Department of Health and Human Services

Enforcement Report - Week of January 23, 2013

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Product Detail

Product Description 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.
Recall Number Z-0691-2013
Classification Class II
Code Info All codes and devices are applicable.
Product Distributed Qty 75 units
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.

Event Detail

Event Id 64039
Product Type Devices
Status Ongoing
Recalling Firm Quanta System, S.p.A.
City Solbiate Olona (VA)
Country IT
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-11-07
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Class II Recall - Worldwide Distribution - USA including TX, AZ, OR, and CO. Only US product is affected by this recall.