P10 Tobii battery box (product number 510410) Product Usage - Battery pack for MyTobii P10 Device. MyTobii P10 is a port

FDA device recall Z-0766-2013 · posted 2013-02-01 · Terminated

Recall details

Recalling firm

Tobii Assistive Technology, Inc.

Reason for recall

Tobii ATI customers P10 external battery pack, which contains sealed lead-acid batteries, malfunctioned while recharging and produced smoke with a chemical smell.

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

ILQ

Quantity affected

483 units

Distribution

US Nationwide Distribution

Date initiated

2013-01-14

Date posted

2013-02-01

Date terminated

2016-07-06

Location

Dedham, MA