Z-0766-2013Class II

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

Name: Z-0766-2013 P10 Tobii battery box (product number 510410) Product Usage - Battery pack for MyTobii P10 Device. MyTobii...
Creator: Tobii Assistive Technology, Inc.
Published: 2013-01-14
License: https://open.fda.gov/license/

Tobii Assistive Technology, Inc. / initiated 2013-01-14 / Terminated / root cause: manufacturing process

FDA source

Tobii Assistive Technology, Inc. began a recall of P10 Tobii battery box (product number 510410) Product Usage - Battery pack for MyTobii P10 Device. MyTobii P10 is a portable eye-controlled communication... on 2013-01-14. FDA classified it as Class II and gives the reason as "Tobii ATI customers P10 external battery pack, which contains sealed lead-acid batteries, malfunctioned while recharging and produced smoke with a chemical smell". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0766-2013
Classification: Class II
Status: Terminated
Initiated: 2013-01-14
Posted: 2013-02-01
Terminated: 2016-07-06
Recalling firm: Tobii Assistive Technology, Inc.
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.
Product code: ILQ System, Communication, Powered
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
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 [email protected].
Quantity in commerce: 483 units
Distribution: US Nationwide Distribution
Product codes and lots: Product Code 510410. All units.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0766-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0766-2013	Class II	Terminated	Voluntary: Firm initiated	2013-02-13	2013-02-01

Product code ILQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)