Quanta System, S.p.A.: Medical Device Recall in 2013 - (Recall #: Z-0691-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: November 7, 2012

Date Posted: January 23, 2013

Recall Number: Z-0691-2013

Event ID: 64039

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.

Status: Terminated

Product Quantity: 75 units

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.

Voluntary or Mandated:

Voluntary: Firm initiated