Events

Retiro De Equipo (Recall) de iBOT 3000 Mobility System. Independence IBOT 3000 Mobility System (Stair-climbing wheelchair), Class III restricted medical device. The device is shipped one each per wooden pallet with wooden sides and top retained by reusable bands.

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 Independence Technology LLC.

¿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
    29482
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1383-04
  • Fecha de inicio del evento
    2004-07-01
  • Fecha de publicación del evento
    2004-08-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2005-02-02
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=33817
  • 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, Stair Climbing - Product Code IMK
  • Causa
    Ibot mobility system may tip over due to malfunction in power base.
  • Acción
    Initial contact to consignees was by telephone on July 2,3,&4 2004. Letters were sent to all consignees from July 5,6,&8, 2004.

Device

iBOT 3000 Mobility System. Independence IBOT 3000 Mobility System (Stair-climbing wheelchair), C...
  • Modelo / Serial
    Catalog No.''s IT000101-IT000148 (inclusive), Vehicle Identification Numbers (''VIN''s):  020404-000347, 020104-000309, 020504-000357, 021203-000308, 020204-000331, 020104-000314, 020104-000318, 021203-000301, 020304-000335, 020104-000310, 020404-000341, 021203-000299, 020204-000330, 020104-000322, 020204-000332, 020404-000350, 020404-000348, 020304-000340, 020404-000346, 020404-000342, 021203-000307, 020204-000333, 020104-000319, 021203-000304, 020404-000352, 020304-000337, 020304-000336, 020504-000356, 020404-000349, 021203-000305, 020604-000360, 020104-000317, 021203-000306, 020504-000358, 020404-000345, 020504-000354, 020304-000334, 020304-000338, 020404-000344, 020404-000351, 020504-000355, 020104-000323, 020104-000324, 021103-000291, 021203-000300, 020304-000339, 020404-000343, 020504-000359, 020604-000363, 020604-000364, 020604-000365, 020604-000366, 020604-000367, 020604-000368, 020604-000362, 021103-000290, 021103-000295, 020104-000315, 020104-000316, 020104-000320, 020104-000311, 020104-000313, 020204-000329, 020504-000353, 020104-000312, 020604-000361, 021003-000280, 020204-000328, 020104-000321, 020204-000326, 021203-000297, 021203-000298, 021203-000303, 020204-000327, 021103-000294, 021103-000286, 021103-000287, 021003-000273, 021103-000282, 021103-000292, 021103-000293, 021003-000276, 021003-000277, 021103-000285, 021103-000289, 020204-000325, 021103-000296, 021003-000278, 021003-000281, 021003-000272, 021003-000279, 021003-000274, 021003-000275, 021103-000283, 021103-000288, 021103-000284, 021203-000302
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    The Independence iBOT 3000 Mobility System was distributed to direct customers in the US, the UK, Ireland, and New Zealand. Ten of the US Direct customers received their devices via the VA. One traning/demo/assessment device was distributed to the firm''s European Support Centre (Ortho Clinical Diagnostics) in France. Two training/demo/assessment devices were distributed to a J&J; representative in Japan.
  • Descripción del producto
    iBOT 3000 Mobility System. Independence IBOT 3000 Mobility System (Stair-climbing wheelchair), Class III restricted medical device. The device is shipped one each per wooden pallet with wooden sides and top retained by reusable bands.
  • Manufacturer
    Independence Technology LLC

Manufacturer

Independence Technology LLC
  • Dirección del fabricante
    Independence Technology LLC, 45 Technology Dr, Warren NJ 07059-5148
  • Source
    USFDA