Events

Retiro De Equipo (Recall) de FHC

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 FHC, 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
    33946
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0179-06
  • Fecha de inicio del evento
    2005-10-31
  • Fecha de publicación del evento
    2005-11-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2006-06-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=42773
  • 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
    Neurological Stereotaxic Instrument - Product Code HAW
  • Causa
    Power assist microtargeting system may advance beyond intended target.
  • Acción
    FHC Inc. and Medtronic notified customers by letter and instructs the customer to return their Motor Option for upgrade to include the following components: 1) Handheld Remote Control, 2) Motor Controller Unit with Display, 3) Motor, and 4) Medical Power Adapter. (See pictures at the end of this communication). Until the Motor Option has been updated, instructions to customers are: Prior to each clinical use: ¿ Ensure the microTargeting Drive system is calibrated before each clinical use per the User Guide. ¿ Check the microTargeting Drive system functionality over a range of at least 10mm movement. ¿ Should any performance indicating either a stall or unintended movement be observed, immediately unplug the 12V Medical Power Adapter, remove the MicroTargeting Drive Motor Option from the system, and continue using the microTargeting Drive in the manual mode. During clinical use: ¿ Should any performance indicating either a stall or unintended movement be observed, immediately unplug the 12V Medical Power Adapter, remove the MicroTargeting Drive Motor Option from the system, and continue using the microTargeting Drive in the manual mode. Every 100 uses or annually: ¿ Have your microTargeting Drive system checked by the manufacturer per the User Guide. ¿ Have your equipment support department check or tighten the MicroTargeting Drive Motor Option Remote Control Knob set screws, tighten as needed, and then re-calibrate.

Device

FHC
  • Modelo / Serial
  • Clasificación del producto
    Neurological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Foreign: South Africa, Taiwan, Hong Kong, China, France
  • Descripción del producto
    FHC microTargeting Power Assist System used with the micro Targeting Drive System, models: 66-DA-ME; 66EL-MC; 66EL-MS;66EL-MS-02; 66-EL-MS-03; 66-EL-RM; MT-DS-AM; MT-DS-MD.
  • Manufacturer
    FHC, Inc.

Manufacturer

FHC, Inc.
  • Dirección del fabricante
    FHC, Inc., 9 Main St, Bowdoinham ME 04008-4418
  • Source
    USFDA