Events

Retiro De Equipo (Recall) de Device Recall FHC microTargeting Guideline 4000

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
    54278
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1143-2010
  • Fecha de inicio del evento
    2009-12-28
  • Fecha de publicación del evento
    2010-03-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-03-18
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88119
  • 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
    Depth Electrode - Product Code GZL
  • Causa
    The raster tab for the gl4k version 1.4 software may assign incorrect depths for waveform recordings and if used to identify the implantation target for the dbs lead, the implant may be placed in the wrong location.
  • Acción
    FHC notified customers by telephone and by an Urgent: Medical Device Correction email, dated December 2009, beginning December 28th. Customers have been instructed to keep the instruction with the GL4K until FHC can provide a revision to the software; and, to use only "distance from zero" or "distance traveled" modes (not "distance from target" mode) during procedures using the raster tab. Customers are to notify their FHC representative to confirm receipt of the notification. A software patch has been verified and validated and will be installed on all affected units. The new version of the corrected software is Guideline 4000 version 1.41. Questions should be directed to Jason Moyer, product manager or Keri Seitz, recall coordinator at 207-666-8190.

Device

Device Recall FHC microTargeting Guideline 4000
  • Modelo / Serial
    Software ver 1.4, Serial Numbers: 19454, 14423, 17349, 19215, 15573, 19424, 17583, 17589, 17588, and 17581. This version of software was released in August 2009
  • Clasificación del producto
    Neurological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA, including states of GA, MA, NC, NJ, OH, RI, TN, TX, and WV and Bucharest, Romania.
  • Descripción del producto
    FHC microTargeting Guideline 4000 ver 1.4 (GL4K) Software, || Catalog # MT-GL4K. || Intended to assist in functional neurological procedures.
  • 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