Events

Rappel de Invacare Storm TDX SR Power Wheelchair with Stability Lock

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
    53871
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0579-2010
  • Date de mise en oeuvre de l'événement
    2009-09-15
  • Date de publication de l'événement
    2009-12-29
  • 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=86767
  • 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
    Powered wheelchair - Product Code ITI
  • Cause
    For some invacare chairs, the stability lock feature may not be engaging properly or consistently. if the stability lock feature does not engage properly, the wheelchair may do one or more of the following: (1) veer to one side; (2) rock forward onto its front riggings; (3) drive in an unintended circular motion; and/or (4) fall forward or to one side. in these cases there is a risk to injury for.
  • Action
    On 9/15/2009 the firm sent recall notification letter to their customers instructing them to immediately contact the dealer to have the stability lock inspected and/or adjusted. If the dealer is unavailable or the repair will take longer than 60 days, they are to contact the firm and arrange for an inspection and/or adjustment. Invacare requested contact names to whom it can send additional information. Invacare plans to mail, via FEDEX, information regarding the recall to each consignee. Initial consignees received a response card and instructions to forward cards to any customer to whom they have distributed the product. The products are to be inspected at the cylinder label and if the label does not have a long alpha-numeric string demonstrated in the label, the cylinders on the chair have to be replaced. Questions are directed to Recalls@Invacare.com or to 800-333-6900.

Device

Invacare Storm TDX SR Power Wheelchair with Stability Lock
  • Modèle / numéro de série
    Model numbers: TDXSR, TDXSR-CG, TDXSR-CG-HD, TDXSR-HD, TDXSR-MCG, TDXSR-MCG-HD, TDXSRV-HD. Serial Numbers: 08BE000082; 08BE000088; 08BE000089; 08BE000090; 08BE000323; 08BE001102; 08BE001105; 08BE002283; 08BE002803; 08BE003025; 08BE003250; 08BE003251; 08BE003472; 08BE003473; 08BE003632; 08BE004402; 08BE004414; 08BE004415; 08BE004835; 08BE005297; 08DE002040; 08EE000277; 08EE001539; 08EE001540; 08EE001775; 08FE003254; 08FE003257; 08FE003668; 08FE004681; 08GE003570; 08GE003936; 08HE001169; 08HE005013; 08IE001081; 08IE001316 & 08IE002729.
  • Classification du dispositif
    Physical Medicine Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Product was distributed to the following states: AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, MA, ME, MI, MN, MO, MS, NC, ND, NM, NY, OH, SC & TX. Product was also distributed in Canada.
  • Description du dispositif
    Invacare Storm TDX SR Power Wheelchair with Stability Lock Model numbers: TDXSR, TDXSR-CG, TDXSR-CG-HD, TDXSR-HD, TDXSR-MCG, TDXSR-MCG-HD, TDXSRV-HD
  • Manufacturer
    Invacare Corporation

Manufacturer

Invacare Corporation
  • Adresse du fabricant
    Invacare Corporation, 1200 Taylor St, Elyria OH 44035-4190
  • Société-mère du fabricant (2017)
    Invacare Corporation
  • Source
    USFDA