Q-Plus T Powered Laser Surgical Instrument Nd:YAG 1064 nm and 532 nm:… — Class II medical device recall Z-0691-2013
Terminated recall by Quanta System, S.p.A., reported 2013-01-23, distributed in AZ, CO, OR, TX. Quanta System S.p.A, Italy, is notifying U.S. consignees that their website contained promotional materials fo
| Recall number | Z-0691-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Quanta System, S.p.A., Solbiate Olona (VA), N/A, Italy |
| Recall initiated | 2012-11-07 |
| Classified | 2013-01-17 |
| Reported by FDA | 2013-01-23 |
| Terminated | 2013-01-23 |
| Distributed | AZ, CO, OR, TX |
| Quantity | 75 units |
Product
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0691-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.