Events

Retiro De Equipo (Recall) de Device Recall LuxStar Dental Light

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 Dental Equipment LLC.

¿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
    59099
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2834-2011
  • Fecha de inicio del evento
    2011-05-27
  • Fecha de publicación del evento
    2011-07-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-10-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=101128
  • 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
    Light, operating, dental - Product Code EAZ
  • Causa
    Lens heat shield (birdcage) of the luxstar dental light could fall and injure a patient.
  • Acción
    Dental Equipment, LLC sent an "URGENT MEDICAL DEVICE RECALL" notification letter via USPS 1st class to US consignees and via Federal Express or Fax to foreign consignees on June 24, 2011. The letter informed customers about the product, problem and tether upgrade corrective action. A Field Correction Acknowledgement Form and the Field Correction Completion Form was attached for customers to complete and return via the fax number 503-537-3617. The letter states that customers are to review their records in order to identify where the affected devices are located and which are still in service. Customers can call the Customer Service at 800-304-5332 and order the self-install Upgrade Kits with the Part Number 30792 at no charge. Customers are instructed to complete the Rework Correction Form once all of the lights have been updated and fax or mail to Marcus, attention Bonnie Dundas, at (503) 537-3617.

Device

Device Recall LuxStar Dental Light
  • Modelo / Serial
    LuxStar Dental Light does not have Serial Number. They are identified by Catalog Model numbers such as ML1000, OL1000, CL1000, WL1000, CB1000, TL1000, and UL1000.
  • Clasificación del producto
    Dental Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA (nationwide) including states of: CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, and Puerto Rico and the countries of: Australia, Belgium, Canada, France, Germany, Ireland, Italy, Mexico, Norway, Poland, Russia, United Kingdom, Vietnam, and Trinidad.
  • Descripción del producto
    LuxStar Dental Light have the following Agency model or Catalog Model numbers as ML1000, OL1000, CL1000, WL1000, CB1000, TL1000, and UL1000. || The product is labeled in part: " Marus Dental***Mfg By: Dental Equipment LLC.***705 S. Springbrook Rd Building C Newberg, Oregon, 97132 USA***Dental Light***MN ML1000***". || Product Usage: The intended use of the dental light is used for illuminating the oral cavity during the performance of dental procedures.
  • Manufacturer
    Dental Equipment LLC

Manufacturer

Dental Equipment LLC
  • Dirección del fabricante
    Dental Equipment LLC, 705 S Springbrook Rd Bldg B200, Newberg OR 97132-7057
  • Source
    USFDA