Events

Rappel de iBOT 3000 Mobility System, Independence iBOT 3000 Mobility System (Stair-climbing wheelchair), Class III restricted medical device.

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Independence Technology LLC.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    29703
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0022-05
  • Date de mise en oeuvre de l'événement
    2004-08-30
  • Date de publication de l'événement
    2004-10-19
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2005-04-01
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=34400
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Wheelchair, Stair Climbing - Product Code IMK
  • Cause
    Rocks and debris can enter into the wheel cluster housing through a damaged wheel cap causing wheel malfunction.
  • Action
    All individuals/organizations in possession of a device were notified by telephone beginning on August 30, 2004. Letters were mailed to all Customers on 8/31/2004 and to all Clinics on 9/1/2004.

Device

iBOT 3000 Mobility System, Independence iBOT 3000 Mobility System (Stair-climbing wheelchair), Cl...
  • Modèle / numéro de série
    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.
  • Classification du dispositif
    Physical Medicine Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    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 training/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.
  • Description du dispositif
    iBOT 3000 Mobility System, Independence iBOT 3000 Mobility System (Stair-climbing wheelchair), Class III restricted medical device.
  • Manufacturer
    Independence Technology LLC

Manufacturer

Independence Technology LLC
  • Adresse du fabricant
    Independence Technology LLC, 45 Technology Dr, Warren NJ 07059-5148
  • Source
    USFDA