Events

Retiro De Equipo (Recall) de Device Recall RSFBG Full Back Conductive Garment

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 International Rehabilitative Sciences, 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
    55578
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2093-2010
  • Fecha de inicio del evento
    2010-05-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-08-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91187
  • 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
    electrode, cutaneous - Product Code GXY
  • Causa
    Device distributed with labeling and ifu outside of their 510(k) clearance.
  • Acción
    The firm, RS Medical, mailed "URGENT NOTICE OF VOLUNTARY CORRECTIVE ACTION" letters dated May 14, 2010, to customers on May 17, 2010 and letters to physicians/consignees on May 19, 2010. The letters included an updated RS-FBG Operation Manual and stated what the update covered; i.e. that the device is indicated for use on the "middle and upper back". The customers were ask to please read your new manual and replace your original RS-FBG Full Back Conductive Garment Operation Manual with this updated version and discard your old RS-FBG Garment Operation Manual. RS Medical stated that your RS-FBG Garment is not affected by this Corrective Action, only the Operation Manual. RS Medical informed the customers that you may continue to use the RS-FBG Full Back Garment with your RS Medical Stimulator as prescribed by your healthcare provider. If you have any questions or concerns, please call our Toll Free Customer Service number at 1-866-417-1293, email us at RSFBG@rsmedical.com or visit our special web page at www.rsmedical.com/rsfbginfo.

Device

Device Recall RSFBG Full Back Conductive Garment
  • Modelo / Serial
    ************All serial numbers from "GA133809" and lower. Code Breakdown: "GA" specific for Full Back Garments; "133809" is a six digit sequential number as devices are manufactured.
  • Clasificación del producto
    Neurological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution.
  • Descripción del producto
    The "RS-FBG Full Back Conductive Garment" with electrode attachments for use with interferential and muscle stimulation with a Transcutaneous Electrical Nerve Stimulation device (TENS) and/or muscle stimulator. || The RS-FBG is a prescription device for use with RS Medical Stimulators to facilitate electrode placement and maintenance of electrode positioning for stimulation treatments. The device is sold individually in several variations for size. It is fitted to the patient and an RS Medical employee gives the patient instructions on how to utilize the device with proper electrode placement in conjunction with the respective TENS/muscle stimulator.
  • Manufacturer
    International Rehabilitative Sciences, Inc.

Manufacturer

International Rehabilitative Sciences, Inc.