Reported Jan 23, 2013 · Terminated
Q-Plus T Powered Laser Surgical Instrument Nd:YAG 1064 nm and 532 nm: Treatment of vascular lesions and pigmented…
Quanta System, S.p.A.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Quanta System, S.p.A. · Via IV Novembre, 116 · Solbiate Olona (VA), N/A · N/A
Is this the product you have?
- Q-Plus
- T Powered Laser Surgical Instrument NdYAG 1064
- nm and 532 nmTreatment of vascular lesions and pigmented lesions; Hair and tattoo removal; The incision, excision, ablation, vaporization of soft tissue for general dermatology
- Ruby 694nmCutting, vaporization and ablation of soft tissue; Tattoo removal; Treatment of benign pigmented lesions
- Lot codes and dates
- All codes and devices are applicable.
- Amount recalled
- 75 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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