Quanta System, S.p.A.: Medical Device Recall in 2013 - (Recall #: Z-0692-2013)
See the recall detail below. You can also see other recalls from the same firm in 2013.
Eterna Giovinezza System, Powered Laser Surgical Instrument. Permanent hair reduction; Photocoagulation of dermatological vascular lesions; Photothermolysis of blood vessels (treatment of facial and leg veins); Treatment of benign pigmented lesions; Inflammatory acne
Class II
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.
All codes and devices are applicable.
Class II Recall - Worldwide Distribution - USA including TX, AZ, OR, and CO. Only US product is affected by this recall.
Voluntary: Firm initiated