FDA Medical Device Recalls (openFDA)
Quanta System, S.p.A.: 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.
- Recall number
- Z-0691-2013
- Recalling firm
- Quanta System, S.p.A.
- 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.
- Status
- Terminated
- Initiated
- 2012-11-07
- Posted
- 2013-01-17
- Terminated
- 2013-01-23
- 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.
- Root cause
- Labeling False and Misleading
- Action
- Quanta System sent a letter dated November 7, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to perform the following: quarantine and destroy all promotional literature printed from the manufacturer, website or obtained from the manufacturer. Provide any promotional literature independently produced by the initial importer or distributor containing information about Quanta System products. Provide URL of initial importers or distributors website if information about Quanta System products is contained therein. Provide a written certification that all actions have been taken. Quanta System has or will: review all promotional materials and website information provided by initial importers and distributors; advise initial importers and distributors of any actions that need to be taken to change promotional materials and/or website information. For questions regarding this recall call 303-223-4336.
- Quantity
- 75 units
- Distribution
- Class II Recall - Worldwide Distribution - USA including TX, AZ, OR, and CO. Only US product is affected by this recall.
- Lot, serial or model codes
- All codes and devices are applicable.
- 510(k) numbers
- ["K073549","K123168"]
- PMA numbers
- not on file
- Product code
- GEX
- Firm FEI
- 3004378299
- Firm city
- Solbiate Olona VA
- Firm state
- not on file
- Firm country
- Italy
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28