P10 Tobii battery box — Class II medical device recall Z-0766-2013
Terminated recall by Tobii Assistive Technology, Inc., reported 2013-02-13, distributed nationwide. Tobii ATI customers P10 external battery pack, which contains sealed lead-acid batteries, malfunctioned while
| Recall number | Z-0766-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Tobii Assistive Technology, Inc., Dedham, MA, United States |
| Recall initiated | 2013-01-14 |
| Classified | 2013-02-01 |
| Reported by FDA | 2013-02-13 |
| Terminated | 2016-07-06 |
| Distributed | Nationwide (US) |
| Quantity | 483 units |
| Reason classes | chemical contamination, device malfunction |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0766-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.