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FDA DevicesClass II

TD Navio Maxi Speech Generating Device Model/Catalog Number: 1000799

Published: August 26, 2026Recall ID: Z-2960-2026Category: Medical DevicesCountry: United States
US
Medical DeviceFDA DevicesUSUS

TD Navio Maxi Speech Generating Device Model/Catalog Number: 1000799

Recalling Firm: Tobii Dynavox Llc

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Reason for Recall / Hazard

Under certain conditions, the battery mounting tabs may become damaged, allowing the battery to move within the device enclosure, potentially leading to an internal short circuit. This may cause localized heating and gas venting within the device enclosure.

Product Description & Identification

TD Navio Maxi Speech Generating Device Model/Catalog Number: 1000799

Affected Products

TD Navio Maxi Speech Generating Device Model/Catalog Number: 1000799

Additional Source Details

FieldValue
CityPittsburgh
StatePA
Event id99410
Address 12100 Wharton St Ste Ste 400
Code infoUDI-DI 073400747602070 Serial Numbers TDNL1-240904000016 through TDNL1-260617070001. Corrected/future production is differentiated by new serialization from TDNL1-260617070001 onward (production batch 20260615, improved design).
Postal code15203-1691
Report date20260826
Product typeDevices
Reason for recallUnder certain conditions, the battery mounting tabs may become damaged, allowing the battery to move within the device enclosure, potentially leading to an internal short circuit. This may cause localized heating and gas venting within the device enclosure.
Voluntary mandatedVoluntary: Firm initiated
Recall initiation date20260708
Initial firm notificationLetter
Center classification date20260814

Consumer Action Protocol: What You Should Do Immediately

Safety Steps
1Verify Product Identifiers

Inspect the NDC code, batch number, or control number on your medicine bottle or blister packaging to confirm whether your unit is included.

2Isolate & Discontinue Use

Do not abruptly stop critical prescribed medication without physician advice. Contact your dispensing pharmacist immediately for a safe alternative.

3Claim Free Statutory Remedy

Under statutory consumer protection rules, consumers are entitled to a full refund, certified replacement, or free repair kit without needing the original sales receipt.

4Report Adverse Incidents

If you suffered an injury, illness, or property damage from this product, file an official incident report with regulatory authorities (FDA Devices).

Your Legal Rights as a Consumer

Recalls are legally binding corrective safety actions overseen by statutory government bodies. Recalling entities are legally prohibited from charging consumers for official safety remedies. If a retailer or dealership refuses your recall remedy, notify the issuing regulatory agency immediately.

Frequently Asked Questions About This Recall

FAQ Guide

Q1:What should I do immediately if I own or bought TD Navio Maxi Speech Generating Device Model/Catalog Number: 1000799?

Check the lot number and NDC on your prescription label. For essential medications, consult your doctor or dispensing pharmacist immediately before abruptly stopping your dose.

Q2:Can I get a full refund or free repair for this recall?

Yes. Recalling manufacturers and retail merchants are required under consumer protection regulations to offer a statutory remedy—typically a full refund, certified repair kit, or replacement unit.

Q3:Do I need my original sales receipt to claim a remedy or refund?

In most recall cases, no receipt is required. Because safety recalls are matters of public health and statutory compliance, retailers and manufacturers routinely issue refunds, store credit, or replacement kits upon presentation of the affected product or lot code.

Q4:Where can I verify official information for this safety alert?

This safety alert is aggregated directly from official regulatory agency records (FDA Devices). You can click the 'Official Agency Alert' link on this page to view the primary government notice and contact the manufacturer directly.

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Overview

  • Recalling FirmTobii Dynavox Llc
  • StatusOngoing
  • Risk LevelClass II
  • DistributionUS Nationwide distribution.
Recall Hazard Severity
High Alert (Class I)
Official Agency Alert

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🚨 SAFETY ALERT: Tobii Dynavox Llc - TD Navio Maxi Speech Generating Device Model/Catalog Number: 1000799

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https://therecallfile.com/recalls/td-navio-maxi-speech-generating-device-model-catalog-number-1000799/FDA-Z-2960-2026
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