Events

Retiro De Equipo (Recall) de Device Recall QPlus T Powered Laser Surgical Instrument

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-0691-2013
  • 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=115258
  • 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 QPlus T Powered Laser Surgical Instrument
  • 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
    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.
  • 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