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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 91884

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
February 24, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Tobii Dynavox Llc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-1399-2023
Recall number
Z-1399-2023
Initiated
February 24, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Tobii Dynavox Llc
Quantity
3924 units

App-derived interpretation

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.