Events

Retiro De Equipo (Recall) de Device Recall Rehab Kidster ( Kidster)

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 Gunnell, 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
    60180
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0863-2012
  • Fecha de inicio del evento
    2011-11-01
  • Fecha de publicación del evento
    2012-01-25
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-08-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105237
  • 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
    Wheelchair, mechanical - Product Code IOR
  • Causa
    Gunnell has received complaints that the gas cylinders used in gunnell manual wheelchairs would not hold a firm position, or as described by users, the back support or canes were spongy in the rehab tough and tilt (tnt), bariatric rehab tough and tilt (btnt), rehab recline and mobility (ram), bariatric rehab recline and mobility (bram), and rehab kidster.
  • Acción
    Gunnell, Inc. sent a Medical Device Correction letters dated November 1, 2011 to all consignees. The letter identified the product, problem, and actions to be taken. The letter states that Gunnell Inc will provide free replacement cylinders and reimburse for each correction verified. The notice instructs customers to complete and return the Response Form. Customers were instructed to notify their customers by including a copy of the correction notice. Question and concerns should be addressed to andy.evancho@gunnell-inc.com. or call 1-800-551-0055, attention Andy Evancho.

Device

Device Recall Rehab Kidster ( Kidster)
  • Modelo / Serial
    Serial numbers: 32357-0904, 33303-1205, 33911-1106, 34312-0107, 34769-0807, 35216-0308, 35314-0408,  35337-0508, 35836-0109, 35669-1008, 35716-1108,  35752-1208, 35764-1208, 35908-0209, 35244-0308,  35627-1008, 35832-0109, 36050-0409, 36744-0610,  36805-0710, 36839-0810, 36849-0810
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) nad the countries of: Australia and Canada
  • Descripción del producto
    Gas cylinders used in Gunnell manual wheelchairs with dynamic recline feature, including: Rehab Kidster( Kidster). || Product Usage: The purpose of these wheelchairs is to provide mobility to individuals limited to a seating position. They may also be used as attendant propelled transport devices in a health care environment such as a hospital, nursing home or extended care facility.
  • Manufacturer
    Gunnell, Inc.

Manufacturer

Gunnell, Inc.
  • Dirección del fabricante
    Gunnell, Inc., 8440 State Rd, Millington MI 48746-9445
  • Source
    USFDA