Z-0691-2013 Class II Terminated
FDA device recall Z-0691-2013 was initiated by Quanta System, S.p.A. on November 7, 2012 and is designated Class II. 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 ther… The recall status is terminated (terminated January 23, 2013). Affected quantity: 75 units.
Recall Details
- Product Type
- Devices
- Report Date
- January 23, 2013
- Initiation Date
- November 7, 2012
- Termination Date
- January 23, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 75 units
Product Description
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.
Distribution Pattern
Class II Recall - Worldwide Distribution - USA including TX, AZ, OR, and CO. Only US product is affected by this recall.
Code Information
All codes and devices are applicable.