FDA Device recall Z-0691-2013
Q-Plus T Powered Laser Surgical Instrument Nd:YAG 1064 nm and 532 nm: Treatment of vascular lesions and pigmented lesions
- FDA Device
- Class II
- terminated
- Published 2013-01-23
On 2013-01-23 the FDA classified a Class II recall of Q-Plus T Powered Laser Surgical Instrument Nd:YAG 1064 nm and 532 nm: Treatment of vascular lesions and pigmented lesions by Quanta System S P A, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0691-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-11-07 |
| Published | 2013-01-23 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Quanta System S P A |
| Distribution | AZ, CO, OR, TX |
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
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.
Identifiers
| code_info | All codes and devices are applicable. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0691-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.