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Recall Observatory FDA recall evidence

Device 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.

Z-0691-2013

November 07, 2012

Class II

Product summary

Firm
Quanta System, S.p.A.
Event
Event 64039
Status
Terminated
Classification
Class II
Quantity
75 units
Official record key
device-enforcement:Z-0691-2013

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.