Z-0691-2013 Class II Terminated
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.