Events

Recall of Device Recall tobii dynavox

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Dynavox Systems Llc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    79433
  • Event Risk Class
    Class 2
  • Event Number
    Z-1305-2018
  • Event Initiated Date
    2017-12-14
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162311
  • Notes / Alerts
    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.
  • Extra notes in the data
    System, communication, powered - Product Code ILQ
  • Reason
    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
  • Model / Serial
    TL1405 TL1407  Part Numbers: T15: 750423 Date Codes are part of the device s unique Serial Number and represent the year and month the device was manufactured.
  • Product Classification
    Physical Medicine Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationally
  • Product Description
    Dynavox T15 Speech Generating Device ( including Batteries)
  • Manufacturer
    Dynavox Systems Llc

Manufacturer

Dynavox Systems Llc
  • Manufacturer Address
    Dynavox Systems Llc, 2100 Wharton St Ste Ste 400, Pittsburgh PA 15203-1691
  • Source
    USFDA