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) |
| State | 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. |
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