Events

Retiro De Equipo (Recall) de Device Recall Ultrawave II EX 1320/ Ultrawave III EX 1320 Powered Laser

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Quanta System, S.p.A..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    64039
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0693-2013
  • Fecha de inicio del evento
    2012-11-07
  • Fecha de publicación del evento
    2013-01-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-01-23
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115260
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Powered laser surgical instrument - Product Code GEX
  • Causa
    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.
  • Acción
    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.

Device

Device Recall Ultrawave II EX 1320/ Ultrawave III EX 1320 Powered Laser
  • Modelo / Serial
    All codes and devices are applicable.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Class II Recall - Worldwide Distribution - USA including TX, AZ, OR, and CO. Only US product is affected by this recall.
  • Descripción del producto
    Ultrawave II EX 1320/ Ultrawave III EX 1320 Powered Laser Surgical Instrument. || Nd:YAG 1064 nm: Coagulation and hemostasis of benign vascular lesions (e.g. port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg and spider veins, scars, straie and psoriasis; Treatment of benign pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments; Treatment of facial wrinkles (e.g. periocular and periorbital); Removal of unwanted hair, for the stable longterm, or permanent, hair reduction, including Fitzpatrick IVI and suntanned skin types; For the treatment of pseudofolliculitis barbae (PFB); Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar; For use on all skin types (Fitzpatrick IVI) including tanned skin. Alexandrite 755 nm: Coagulation and hemostasis of vascular lesions and the removal and permanent reduction of unwanted hair in Fitzpatrick skin types 1VI, including suntanned skin types; Pigmented lesions; Wrinkles. Nd: YAG 1320 nm: General surgery and dermatology for the incision, excision, ablation, vaporization, coagulation and hemostasis of soft tissue; Treatment of periorbital and periocular wrinkles, fine lines and wrinkles, treatment of back acne and atrophic acne scars. IPL: Permanent hair reduction; Photocoagulation of dermatological vascular lesion (i.e. face telangiectasia); Photothermolysis of blood vessels (treatment of facial and leg veins); Treatment of benign pigmented lesions.
  • Manufacturer
    Quanta System, S.p.A.

Manufacturer

Quanta System, S.p.A.
  • Dirección del fabricante
    Quanta System, S.p.A., Via IV Novembre, 116, Solbiate Olona (VA) Italy
  • Empresa matriz del fabricante (2017)
    El.En. SpA
  • Source
    USFDA