Events

Rappel de Device Recall Dragonfly 2Channel Laryngeal Surface Electrode

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 Neurovision Medical Products Inc.

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
    54233
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0798-2010
  • Date de mise en oeuvre de l'événement
    2010-01-11
  • Date de publication de l'événement
    2010-02-22
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-04-21
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=87916
  • 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
    stimulator, nerve - Product Code ETN
  • Cause
    This recall has been initiated due to a conductive glue used to attach the lead wire to electrode, which has been found in a small number of electrodes, to cause a short circuit in one of the channels. this is due to migration of the adhesive from one pad to the other creating an electrical short. use of one of these defective electrodes could lead to a failure to monitor. our investigation has c.
  • Action
    URGENT RECALL: Medical Device Letter dated 1/7/10. The letter identified the affected product and provided a list of necessary actions for customers to take. The customers should immediately examine their inventory and quarantine product subject to recall. In addition, if they have further distributed this product, please identify their customers and notify them at once of this product recall. Their notification to their customers may be enhanced by including a copy of this recall notification letter. This recall should be carried out to the user level. Your assistance is appreciated and necessary to prevent any failure to monitor. Please complete and return the enclosed response form as soon as possible. If you have any questions, call Ryan Rea or Kevin Rea, at 866-815-6999.

Device

Device Recall Dragonfly 2Channel Laryngeal Surface Electrode
  • Modèle / numéro de série
    Lot numbers 113008, 054409, 096709
  • Classification du dispositif
    Ear, Nose, and Throat Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide: CA CO FL GA IL LA MI ND NY OH PA TX UT WA WI)
  • Description du dispositif
    2-Channel Laryngeal Surface Electrode (Model LSE500DCS and LSE500DCL) || For use as a Surgical stimulator/locator for recurrent laryngeal nerve.
  • Manufacturer
    Neurovision Medical Products Inc

Manufacturer

Neurovision Medical Products Inc
  • Adresse du fabricant
    Neurovision Medical Products Inc, 275 Burnett Ave, Ventura CA 93003
  • Société-mère du fabricant (2017)
    Neurovision Medical Products Inc
  • Source
    USFDA