Events

Rappel de Device Recall TRUBalance3 Power Positioning System

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 Pride Mobility Products Corp.

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
    75881
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0942-2017
  • Date de mise en oeuvre de l'événement
    2016-12-01
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151534
  • 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
    The interface between the tb3 back and tilt base can separate when tilted beyond the specified angle.
  • Action
    Pride Mobility Products Corp. mailed a letter to affected customers to inform them of the issue. Systems were not required to be returned. Customers were informed that a TB3 Seat Depth Adjustment Reinformcement Kit which contains (2) reinforcement plates and associated hardware to strengthen the interface will be installed to address the issue. Direct accounts were asked to contact patients to inform them of the product correction. Customers were also requested to complete and return Pride's completion card once the correction has been made. Pride will issue a $65.00 credit once the completion card is received. Customers with questions were instructed to call Pride's Upgrade Department at 866-222-6212. For questions regarding this recall call 800-800-8586.

Device

Device Recall TRUBalance3 Power Positioning System
  • Modèle / numéro de série
    Numerous serial numbers affected (12,343 units)
  • Classification du dispositif
    Physical Medicine Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    TRU-Balance 3 Power Positioning Systems, TB3 Lift/Tilt/Recline (Gen 1). || Mobility Medical Device
  • Manufacturer
    Pride Mobility Products Corp

Manufacturer

Pride Mobility Products Corp
  • Adresse du fabricant
    Pride Mobility Products Corp, 182 Susquehanna Ave, Exeter PA 18643-2653
  • Société-mère du fabricant (2017)
    Pride Mobility Products Corp
  • Source
    USFDA