Events

Rappel de Device Recall tobii dynavox

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 Dynavox Systems 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
    79433
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1304-2018
  • Date de mise en oeuvre de l'événement
    2017-12-14
  • 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=162310
  • 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
    System, communication, powered - Product Code ILQ
  • Cause
    The battery is integral to the device. if the device sits unused and is not charged for a lengthy period of time (a few months) the battery will go into a deep discharge state and the battery will expire. the battery may out-gas which may be described as swelled or puffed, as gas is trapped inside the pack surrounding the cells. this battery may cause the device case to separate a small amount.
  • Action
    On February 26, 2018 an URGENT MEDICAL RECALL LETTER was issued to customers with the subject line listing the serial number specific to that customer along with the date of purchase. The letter informs customers of the issue and instructs customers to return product to one of their facilities to have the product repaired until an RA. Questions or concerns can be directed to 1-800-344-1778, Press 1 and then Press 2.

Device

Device Recall tobii dynavox
  • Modèle / numéro de série
    TS1308 TS1411  Part Numbers: T10: 750394  Date Codes are part of the device s unique Serial Number and represent the year and month the device was manufactured.
  • Classification du dispositif
    Physical Medicine Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationally
  • Description du dispositif
    Dynavox T10 Speech Generating Device ( including Batteries)
  • Manufacturer
    Dynavox Systems Llc

Manufacturer

Dynavox Systems Llc
  • Adresse du fabricant
    Dynavox Systems Llc, 2100 Wharton St Ste Ste 400, Pittsburgh PA 15203-1691
  • Source
    USFDA