Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1305-2018 — Dynavox T15 Speech Generating Device ( including Batteries)

U.S. FDA — Device Enforcement · United States · 2017-12-14 · Class II

AI-assisted, human-edited — this page is drafted with AI from public-source data, then reviewed before publication. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1305-2018
Date of alert
2017-12-14
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Dynavox Systems Llc
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

Related

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.