Events

Recall of Device Recall P10 Tobii battery pack

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Tobii Assistive Technology, Inc..

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
    64099
  • Event Risk Class
    Class 2
  • Event Number
    Z-0766-2013
  • Event Initiated Date
    2013-01-14
  • Event Date Posted
    2013-02-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-07-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115353
  • 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
    Tobii ati customers p10 external battery pack, which contains sealed lead-acid batteries, malfunctioned while recharging and produced smoke with a chemical smell.
  • Action
    The recalling firm, Tobii Assistive Technology, Inc. sent a notification letter to all customers who received the recalled product via certified mail. The letter identified the affected product, problem and actions to be taken. Customers were instructed to immediatley discontinue the use of the P10 battery pack and provded with instructions to receive a complimentary replacement solution. The letter instructed customers to dispose of their P10 External Battery Pack in a manner stipulated with local laws. An acknowledgment form is included to be completed by customers. For questions contact Tobii ATI at 1-800-793-9227 or P10batterypack@tobiiati.com.

Device

Device Recall P10 Tobii battery pack
  • Model / Serial
    Product Code 510410. All units.
  • Product Classification
    Physical Medicine Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution
  • Product Description
    P10 Tobii battery box (product number 510410) || Product Usage - Battery pack for MyTobii P10 Device. MyTobii P10 is a portable eye-controlled communication device featuring the Tobii Eye Control system.
  • Manufacturer
    Tobii Assistive Technology, Inc.

Manufacturer

Tobii Assistive Technology, Inc.
  • Manufacturer Address
    Tobii Assistive Technology, Inc., 333 Elm St, Dedham MA 02026-4530
  • Source
    USFDA