Tobii Dynavox TD I-110 Speech Device-tablet style speech generating device used for ambulatory people with disabilities
Summary
The FDA issued a Class II for Tobii Dynavox TD I-110 Speech Device-tablet style speech generating device used by Tobii Dynavox Llc. Reason: Problem maintaining the stable placement of the battery may come loose from the housing and become damaged..
Details
Source
Device Recall
External ID
Z-1399-2023
Action Date
2023-04-26
Status
Ongoing
Category
device
Product Description
Tobii Dynavox TD I-110 Speech Device-tablet style speech generating device used for ambulatory people with disabilities. Catalog #: 750567
Lot/Code Info: UDI: 7340074601714 Serial Numbers: TD110-211005000001 through TD110-220927004400
Quantity Affected: 3924 units
Reason for Recall
Problem maintaining the stable placement of the battery may come loose from the housing and become damaged.
Distribution
Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Belgium, Brazil, Canada, Croatia, Denmark, Estonia, Finland, France, Germany, Iceland Ireland, Italy, Latvia, Netherlands, Norway, Saudi Arabia, Slovakia, Slovenia, Sweden, United Arab Emirates, United Kingdom.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-02-24
Company
Pittsburgh, PA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 134 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Tobii Dynavox Llc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Tobii Dynavox Llc have FDA actions?
This is the only FDA action we have on record for Tobii Dynavox Llc in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1399-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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