The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0766-2013·Announced 2013-02-13

Tobii P10 Battery Box Recalled for Smoke and Chemical Smell During Recharging

Tobii Assistive Technology is recalling 483 P10 battery boxes that malfunctioned while recharging, producing smoke and a chemical smell.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (fire/smoke hazard) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Tobii Assistive Technology, Inc. is recalling 483 units of the P10 Tobii battery box (product number 510410). This battery pack is used for the MyTobii P10, a portable eye-controlled communication device. The units were distributed nationwide in the United States.

The recall was initiated because the external battery packs, which contain sealed lead-acid batteries, malfunctioned while recharging. During these malfunctions, the units produced smoke and emitted a chemical smell.

Consumers who have this product should stop using it immediately. The source text does not provide specific instructions for disposal or replacement, but users should contact Tobii Assistive Technology for further guidance.

The recalled product

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.
Manufacturer
Tobii Assistive Technology, Inc.
Category
Medical Device — Assistive Technology
Hazard
Affected units
483

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Product Code 510410. All units.

Distribution

Distributed nationwide across the United States.

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