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Recall Observatory FDA recall evidence

Device product

Tobii Dynavox TD I-110 Speech Device-tablet style speech generating device used for ambulatory people with disabilities. Catalog #: 750567

Z-1399-2023

February 24, 2023

Class II

Product summary

Firm
Tobii Dynavox Llc
Event
Event 91884
Status
Ongoing
Classification
Class II
Quantity
3924 units
Official record key
device-enforcement:Z-1399-2023

Official wording

Reason: Problem maintaining the stable placement of the battery may come loose from the housing and become damaged.

Code information: UDI: 7340074601714 Serial Numbers: TD110-211005000001 through TD110-220927004400

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Problem maintaining the stable placement of the battery may come loose from the housing and become damaged.