Events

Retiro De Equipo (Recall) de Device Recall MicroSpeed Uni Motor 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 Aesculap 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
    57419
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1474-2011
  • Fecha de inicio del evento
    2010-11-22
  • Fecha de publicación del evento
    2011-03-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-07-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96168
  • 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
    Motor, drill, electric - Product Code HBC
  • Causa
    Potential safety issue in that the control box can misinterpret the information sent from the low speed motor if the control magnet inside the motor changes its posthion.
  • Acción
    AESCULAP sent an IMPORTANT CORRECTION NOTICE letter dated November 22, 2010, to all affected consignees. The letter identified the product, the problem, and the action the consignee should take. Consignees were instructed to not use the motors for thread cutting and removal of screws. If any unusual reactions of any cutting tools were observed consignees should check to ensure that the motor is not running in the opposite direction. If any error message is displayed, consigness were instructed to not use the motor. Consignees were also instructed to check both directions of running before use and do not use a motor which produces an error message in one direction. Aesculap would be providing all customers with a software update to the MicroSpeed Uni control box either by the unit being returned to Aesculap for update or by firm representative doing the upgrade on site at their facility. For questions regarding this recall call 800-258-1946 x5254 or 800-258-1946 x5267.

Device

Device Recall MicroSpeed Uni Motor System
  • Modelo / Serial
    Part #GD670 - all distributed lot numbers and serial numbers
  • Clasificación del producto
    Neurological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including CA, CO, DE, FL, GA, IN, LA, MO, NC, NJ, OK, PA, TN, TX, and VA and the country of Canada.
  • Descripción del producto
    Aesculap MicroSpeed Uni Control Box, Part #GD670 || Intended for high speed cutting, sawing, drilling and manipulation of soft tissue and bone in the fields of Spine, ENT, Neuro and Maxillo facial Surgery.
  • Manufacturer
    Aesculap Inc

Manufacturer

Aesculap Inc
  • Dirección del fabricante
    Aesculap Inc, 3773 Corporate Pkwy, Center Valley PA 18034-8217
  • Empresa matriz del fabricante (2017)
    Ludwig G. Braun Gmbh U. Co. Kg
  • Source
    USFDA