Tobii Dynavox TD I-110 Speech Device Recalled Over Loose Battery Risk
The FDA is recalling the Tobii Dynavox TD I-110, a speech-generating device, because the battery may become loose from its housing and potentially be damaged. This affects users worldwide who depend on this device for communication.
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: FDA Class II recall with no reported illnesses or injuries. The hazard is potential battery loosening without documented cases of actual harm, limiting severity to High per the rubric criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
The FDA is recalling 3,924 units of the Tobii Dynavox TD I-110 speech-generating device. This tablet-style device is designed for ambulatory people with disabilities to use for communication.
The device has a battery placement issue. The battery may become loose from its housing and be damaged. This recall was initiated by the manufacturer, Tobii Dynavox Llc.
The affected units were distributed worldwide, including throughout the United States and internationally to Argentina, Australia, Belgium, Brazil, Canada, Croatia, Denmark, Estonia, Finland, France, Germany, Iceland, Ireland, Italy, Latvia, Netherlands, Norway, Saudi Arabia, Slovakia, Slovenia, Sweden, the United Arab Emirates, and the United Kingdom. Affected units can be identified by serial number (TD110-211005000001 through TD110-220927004400) or UDI (7340074601714).
Owners of affected devices should refer to the FDA's website or contact the manufacturer for further information about this recall.
The recalled product
- Product
- Tobii Dynavox TD I-110 Speech Device-tablet style speech generating device used for ambulatory people with disabilities. Catalog #: 750567
- Manufacturer
- Tobii Dynavox Llc
- Affected units
- 3,924
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)
- UDI: 7340074601714 Serial Numbers: TD110-211005000001 through TD110-220927004400
Distribution
Distributed nationwide across the United States.
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