Events

Retiro De Equipo (Recall) de Device Recall SEAC Advanced Dental System

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 ASI Medical, Inc..

¿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
    66983
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0545-2014
  • Fecha de inicio del evento
    2013-11-05
  • Fecha de publicación del evento
    2013-12-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-08-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124413
  • 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
    Unit, operative dental - Product Code EIA
  • Causa
    Asi medical is initiating a field correction for the seac advanced dental system because the miniature plastic air tank can potentially rupture.
  • Acción
    ASI Medical sent an Field Correction Action and Safety Notice letter dated November 5, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. REQUIRED FIELD CORRECTION Our field correction will consist of sending you a warning label to be applied to the back service access panel of the cart and an ASME safety pop off valve that will open and exhaust if pressure should reach over 100 psi. This safety pop off valve is designed be easily installed in line between the air compressor and air tank in your system. We are requesting your cooperation in making this field correction.

Device

Device Recall SEAC Advanced Dental System
  • Modelo / Serial
    Code No: 2010, 2020,2120 and 2220 Serial No: 590341- 592066
  • Clasificación del producto
    Dental Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) including the countries of Austria, Aruba, Saudi Arabia, Canada, Germany, Spain and West Indies.
  • Descripción del producto
    SEAC Advanced Dental System, Model A591561 || The SEAC Advanced Dental System is a self-contained dental delivery system with a built-in air compressor,vacuum system and water supply. It is designed operate dental handpiece attachments and suction instruments. The SEAC Advanced Dental System can also be upgraded to include a Micadent air abrasion system mounted inside the unit with the handpiece mounted in a holder along side the other handpiece connections. The Micadent is used to perform intra¿ oral air abrasion procedures including etching and preparing surfaces for composite restoration. The SEAC Advanced Dental System is substantially similar in design and functions as the SEAC Mobile Dental System manufactured by ASI Medical, Inc. The Micadent is manufactured by Medidents and will be supplied to ASIas a completed product. The Micadent is substantially the same as it is provided and is attached to an accessory air line inside the SEAC unit for operation. It is intended for use to provide general dental restorative care and hygiene procedures in both traditional dental office settings and/or mobile applications by or under the supervision of a licensed dentist or a hygienist if permitted by applicable law.
  • Manufacturer
    ASI Medical, Inc.

Manufacturer

ASI Medical, Inc.
  • Dirección del fabricante
    ASI Medical, Inc., 14550 E Easter Ave Ste 700, Centennial CO 80112-4271
  • Empresa matriz del fabricante (2017)
    Asi Medical Inc.
  • Source
    USFDA