FDAFDA · Food and drugs·Recall number Z-0692-2013
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
Published January 23, 2013 · Recall initiated: November 7, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Quanta System, S.p.A.
- Distributor
- Class II Recall - Worldwide Distribution - USA including TX, AZ, OR, and CO. Only US product is affected by this recall.
- Lot
- All codes and devices are applicable.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Italy
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