Enforcement Report - Week of January 23, 2013
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Product Detail
| Product Description | 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 |
|---|---|
| Recall Number | Z-0692-2013 |
| Classification | Class II |
| Code Info | All codes and devices are applicable. |
| Product Distributed Qty | 12 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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