Recall Z-1399-2023— Tobii Dynavox Llc

Name: FDA recall Z-1399-2023
Creator: U.S. Food and Drug Administration
Published: 2023-02-24

Class II · Ongoing

Class II FDA medical device recall by Tobii Dynavox Llc, initiated 2023-02-24. FDA's recall record names no specific 510(k) clearance for this event. Product: Tobii Dynavox TD I-110 Speech Device-tablet style speech generating device used for ambulatory people with disabilities. Catalog #: 750567. Reason: Problem maintaining the stable placement of the battery may come loose from the housing and become damaged..

Recalling firm: Tobii Dynavox Llc
Classification: Class II
Status: Ongoing
Initiated: 2023-02-24
Firm location: Pittsburgh, PA, United States

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.