Events

Rappel de Device Recall TDX SP Power Wheelchair

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 Invacare Corporation.

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
    61160
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1201-2012
  • Date de mise en oeuvre de l'événement
    2012-02-10
  • Date de publication de l'événement
    2012-03-12
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-08-25
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107440
  • 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, powered - Product Code ITI
  • Cause
    Invacare corporation decided to recall the product because use of this actuator could result in reduced cross sectional current carrying area due to wear/chafing of the wires.
  • Action
    The firm, Invacare, sent an "URGENT: RECALL INFORMATION" letter dated February 10, 2012 to their consignees/customers. The letter described the product, problem and actions to be taken. Invacare has developed retrofit kits intended to address this issue. The consignees were instructed to contact the customers that have potentially affected product and perform the necessary updates. The consignees were also instructed to complete and return the Provider Response Form to order the retrofit kit. If you have any questions, please contact Customer Service at 1-800-333-6900.

Device

Device Recall TDX SP Power Wheelchair
  • Modèle / numéro de série
    Model# TDXDP-CG, Serial# 11HE001056; Model# TDXP-CG, Serial# 11GE004364, 11HE000039; Model# TDXSP-CG, Serial# 11GE001580, 11GE001593, 11GE001874, 11GE001886, 11GE001919, 11GE001919, 11GE001920, 11GE002363, 11GE002455, 11GE002456, 11GE002464, 11GE002622, 11GE002625, 11GE002635, 11GE002839, 11GE002850, 11GE003048, 11GE003075, 11GE003249, 11GE003258, 11GE003500, 11GE003503, 11GE003687, 11GE003690, 11GE003931, 11GE003934, 11GE004230, 11GE004354, 11GE004355, 11GE004356, 11GE004359, 11GE004361, 11GE004490, 11GE004638, 11GE004642, 11HE000047, 11HE000333, 11HE000335, 11HE000343, 11HE000344, 11HE000508, 11HE000748, 11HE000749, 11HE000752, 11HE000755, 11HE000848, 11HE001057, 11HE001243, 11HE001244, 11HE001246, 11HE001311, 11HE001515, 11HE001645, 11HE001647, 11HE001653, 11HE001659, 11HE001838, 11HE001843, 11HE00756; Model# TDXSP-CG-GT, Serial# 11GE001891, 11GE002134, 11GE002849, 11GE003064, 11GE003504; Model# TDXSP-CT-GT, Serial# 11GE002849; Model# TDXSP-MCG, Serial# 11GE000322, 11GE001567, 11GE001894, 11GE002136, 11GE002137, 11GE002372, 11GE002376, 11GE002377, 11GE002378, 11GE002382, 11GE002383, 11GE002385, 11GE002657, 11GE002852, 11GE003065, 11GE003067, 11GE003070, 11GE003073, 11GE003252, 11GE003261, 11GE003263, 11GE003266, 11GE003711, 11GE003712, 11GE003938, 11GE004134, 11GE004135, 11GE004368, 11HE000055, 11HE000102, 11HE000348, 11HE000511, 11HE000761, 11HE001250, 11HE001450, 11HE002071 & 11HE002523.
  • Classification du dispositif
    Physical Medicine Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) including states of: AZ, CA, CT, FL, GA, IA, IL, IN, KY, ME, MI, MN, MO, MT, NC, NE, NJ, NY, OH, RI, SD, TX, VA, WA, and WI; and countries of: Australia, Canada and New Zeland.
  • Description du dispositif
    TDX SP Power Wheelchair, Model #'s: TDXSP-CG, TDXSP-CG-GT, TDXSP-MCG, TDXSP-MCG-GT, Distributed By: || Invacare Corporation, Elyria, OH 44035 || The Invacare TDX power wheelchair is a battery powered, motor driven device with the intended function and use of providing mobility to those persons limited to a sitting position that have the capability of operating a power wheelchair. It is a rigid or non-folding type power wheelchair, with mid wheel drive capability.
  • Manufacturer
    Invacare Corporation

Manufacturer

Invacare Corporation
  • Adresse du fabricant
    Invacare Corporation, 1 Invacare Way, Elyria OH 44035-4190
  • Société-mère du fabricant (2017)
    Invacare Corporation
  • Source
    USFDA