Events

Retiro De Equipo (Recall) de Device Recall Dental chair headrest

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
    55153
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2241-2010
  • Fecha de inicio del evento
    2010-03-23
  • Fecha de publicación del evento
    2010-08-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-01-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90151
  • 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
    Dental chair headrest - Product Code NRU
  • Causa
    The magnetic headrest on certain dental chairs may affect the function/programming of some implantable pacemakers or defibrillators if the implanted device is programmed to respond to a magnet.
  • Acción
    DCI Equipment sent an "Urgent Field Safety Alert" letter dated March 15, 2010 to consignees advising them of the potential problem. The letter instructed that patients with implantable pacemakers or defibrillators should avoid dental chairs with the magnetic headrest. A warning label was sent with the letter for insertion into the product Use and Care manual for operator warning. Consignees were asked to complete a Field Safety Alert Acknowledgement/Return Form and fax to the firm. Consignees were requested to notify customers.Consignees may contact the firm at 503 537-3602.

Device

Device Recall Dental chair headrest
  • Modelo / Serial
    The individual headrests do not have serial numbers. The headrest has a part number of "40R501". The part number is followed by a dash and a 2 or 3 digit number that indicates the color of the vinyl covering.
  • Clasificación del producto
    Dental Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution in the USA and Canada.
  • Descripción del producto
    The magnetic headrest is designed to fit the following dental chairs (THE HEADREST IS THE RECALLED ITEM, NOT THE CHAIRS): || The dental chairs are sold under the brand names Marus and DCI Equipment. The affected models are: || Marus MaxStar-Agency Model # DC1490; || Marus MaxStar-Agency Model # DC1690; || Marus NuStar-Agency Model # DC1700; || Marus NuStar-Agency Model # DC1702; || Marus ProStar-Agency Model # DC1540; || Marus ProStar-Agency Model # DC1535; || DCI Equipment DC1235 Hydraulic-Agency Model # DC1235; and || DCI Equipment DC1335 Electromechanical-Agency Model # DC1335.
  • 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