Skip to content
Recall Observatory FDA recall evidence

Device product

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

Z-0692-2013

November 07, 2012

Class II

Product summary

Firm
Quanta System, S.p.A.
Event
Event 64039
Status
Terminated
Classification
Class II
Quantity
12 units
Official record key
device-enforcement:Z-0692-2013

Official wording

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.

Code information: All codes and devices are applicable.

Distribution pattern: Class II Recall - Worldwide Distribution - USA including TX, AZ, OR, and CO. Only US product is affected by this recall.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.