Events

Retiro De Equipo (Recall) de Device Recall microTargeting Drive 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 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
    55287
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0311-2011
  • Fecha de inicio del evento
    2010-03-30
  • Fecha de publicación del evento
    2010-11-03
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-02-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90478
  • 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
    Fixation thumbscrew on the dbs depth stop adapter may be overtightened and damage the implantable lead.
  • Acción
    FHC issued an "URGENT: MEDICAL DEVICE CORRECTION" letter dated March 29, 2010, to all customers. The letter described the product, problem and actions to be taken by the customers. FHC informed the customers that that they had returned to the original design of the fixation screw in the Depth Stop Adapter. FHC sent replacement Depth Stop Adapter with an original fixation screw. The customers were instructed to discard the recalled Depth Stop Adapter (s) and replace with the enclosed corrected version(s) and sign and fax the receipt notification to 207-666-8309 as proof of their receipt of notification. For assistance with the product replacement, contact the FHC's technical support line at 800-326-2905. This line is staffed 24 hours a day. Should you have any further questions regarding this matter, please contact Dorothee Sasse, product manager, or Keri Seitz, recall coordinator at 207-666-8190.

Device

Device Recall microTargeting Drive System
  • Modelo / Serial
    Serial Numbers: 14511,16997, 15104  Medtronic: 15140,15108, 15084, 15081, 21380, 21375, 15153, 15107, 15118, 15098, 15092, 15071, 21372, 21389, 21386 Manufactured after January 21, 2010 and prior to March 22, 2010.
  • Clasificación del producto
    Neurological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA in the states of AZ, CA, FL, ID, NC, MA, MI, MN, NV, RI, UT, VA, and WA, and countries of Columbia and South Africa.
  • Descripción del producto
    microTargeting Drive System with Mounted Accessories || Catalog numbers : 66-ZD-MD-01, MT-DS-01, FC1006 (Medtronic) || Product is the FHC DBS Depth Stop Adapter, a component of the microTargeting Drive and the STar Drive. The Drives are intended to be used with commercially available stereotactic systems for neurosurgical procedures which require the accurate positioning of microelectrodes, stimulating electrodes, or other instruments in the brain or nervous system.
  • Manufacturer
    FHC, Inc.

Manufacturer

FHC, Inc.
  • Dirección del fabricante
    FHC, Inc., 1201 Main Street, Bowdoinham ME 04008
  • Empresa matriz del fabricante (2017)
    Fhc Inc.
  • Source
    USFDA