Events

Rappel de Device Recall Harmony HiResolution Bionic Ear 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 Advanced Bionics LLC.

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
    52700
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2039-2009
  • Date de mise en oeuvre de l'événement
    2009-06-10
  • Date de publication de l'événement
    2009-09-11
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-03-26
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83675
  • 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
    Implant, cochlear - Product Code MCM
  • Cause
    The recall was initiated after advanced bionics became aware of fourteen (14) devices manufactured between may 27, 2005 and june 30, 2005 that are confirmed to have or potentially have an issue related to the internal magnet. these devices are were made with an internal magnet where the metal case surrounding the magnet was not properly welded. patients with these devices may experience a decreas.
  • Action
    Advanced Bionics, LLC issued an "Important Notification" dated June 10, 2009 via Fed Ex to Consignees in the US and Canada. Outside of the US, the notification letters will be distributed in such a manner that delivery confirmation can be obtained. There were three type of notification letters distributed: one for Patients, one for Surgeons and one for Clinicians. Letters described the affected device prompting users on what to do next. An acknowledgement form was enclosed and should be completed and sent via fax to 1-661-362-7621. For further information, contact Advanced Bionics at 1-877-829-0026.

Device

Device Recall Harmony HiResolution Bionic Ear system
  • Modèle / numéro de série
    Serial Numbers: 225271, 301184, 225466, 225647, 225289, 225187, 300922, 225629, 225512, 301129, 300926, 225272, 225373, 300980, 225281, 225423, 225540 and 301027.
  • Classification du dispositif
    Ear, Nose, and Throat Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution -- US, Canada, France and South Korea.
  • Description du dispositif
    Advanced Bionics HiRes 90K Cochlear Implant, Model: CI-1400-01 and CI-1400-02H, Implant Magnet Case. || Cochlear implant intended to restore a level of auditory sensation to patients with profound sensorineural deafness via electrical stimulation of the auditory nerve.
  • Manufacturer
    Advanced Bionics LLC

Manufacturer

Advanced Bionics LLC
  • Adresse du fabricant
    Advanced Bionics LLC, 12740 San Fernando Rd, Sylmar CA 91342-3728
  • Société-mère du fabricant (2017)
    Sonova Holding Ag
  • Source
    USFDA