Recall Z-0766-2013— Tobii Assistive Technology, Inc.
Class II · Terminated
Class II FDA medical device recall by Tobii Assistive Technology, Inc., initiated 2013-01-14, terminated 2016-07-06. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: Tobii ATI customers P10 external battery pack, which contains sealed lead-acid batteries, malfunctioned while recharging and produced smoke with a chemical smell..
- Recalling firm
- Tobii Assistive Technology, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-01-14
- Terminated
- 2016-07-06
- Firm location
- Dedham, MA, United States
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.