Events

Rappel de Device Recall Jazzy Select 6 with XLR Port Harness

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
    54617
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2619-2010
  • Date de mise en oeuvre de l'événement
    2010-02-01
  • Date de publication de l'événement
    2010-09-29
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-11-20
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88792
  • 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
    Improper set-up of the wire harness can allow wires to be pulled from their intended position and become caught under the motor mounting bracket located under the powered wheelchair. this can cause the wire connector and/or the wire itself to be pulled or pinched which can lead to a short or open circuit.
  • Action
    The recalling firm issued recall notifications with response cards to their dealers. Included with the notification was fasteners and an example letter for customer notification of the problem. Dealers were instructed to contact the end users to make arrangements with the customer/end user to verify that the devices were properly set up. If the dealers' inspection revealed that additional fasteners were required they dealer would install them. The recalling firm also issued a recall letter to consumers. The consumer recall letter included instructions that if the correction was completed by anyone other than the wheelchair provider, then the consumer should schedule an appointment with the wheelchair provider to ensure the correction was completed properly.

Device

Device Recall Jazzy Select 6 with XLR Port Harness
  • Modèle / numéro de série
    all serial numbers
  • Classification du dispositif
    Physical Medicine Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    The product was shipped to dealers nationwide who further shipped the product to end users. The product was also shipped to distributors in Canada, Australia and United Kingdom
  • Description du dispositif
    Jazzy Select 6 with XLR Port Harness
  • Manufacturer
    Pride Mobility Products Corp

Manufacturer

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