Recall record at a glance
| Official record | Z-1305-2018 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Dynavox Systems LLC |
| Report date | Apr 11, 2018 |
| Recall initiation date | Dec 14, 2017 |
| Quantity | 307 |
| Location | Pittsburgh, PA, United States |
Official product description
Dynavox T15 Speech Generating Device ( including Batteries)
Why the product was recalled
The battery is integral to the device. If the device sits unused and is not charged for a lengthy period of time (a few months) the battery will go into a deep discharge state and the battery will expire. The battery may out-gas which may be described as swelled or puffed, as gas is trapped inside the pack surrounding the cells. This battery may cause the device case to separate a small amount.
Distribution information
Nationally
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
FDA source limitation: openFDA enforcement reports are a reference dataset, not a live public-alert or recall-lifecycle service. FDA notes that enforcement-report status may not be updated after classification. Confirm current actions with the FDA, recalling firm or appropriate healthcare professional when relevant.