FDAFDA · Alimentos y medicamentos·N.º oficial Z-0691-2013
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.
Publicado el 23 de enero de 2013 · Inicio del retiro: 7 de noviembre de 2012
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
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.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Quanta System, S.p.A.
- Distribuidor
- Class II Recall - Worldwide Distribution - USA including TX, AZ, OR, and CO. Only US product is affected by this recall.
- Lote
- All codes and devices are applicable.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- Italy
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