FDAFDA · Food and drugs·Recall number Z-0691-2013
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.
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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