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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 63166

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

Open FDA event record

Event summary

Timeline bucket
May 13, 2008
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Toshiba American Medical Systems Inc

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

TSX-301A/2 Aquilion One CT System. The TSX-30IAl2 is a whole body CT scanner. This device captures cross sectional volume data sets. The device consists of a gantry, patient couch (table) and peripheral cabinets used for data processing and display. This device is intended to produce cross sectional volume sets of the anatomy. Additionally the system, when used by a trained professional, is capable of proving data for dynamic and perfusion studies of organs and extremities.

Z-2468-2012
Recall number
Z-2468-2012
Initiated
May 13, 2008
Classification
Class II
Status
Terminated
Quantity
3 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The SureStart function may not operate in the usual manner, and you may obtain abnormal analysis results when using the cerebral blood flow analysis function.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The SureStart function may not operate in the usual manner, and you may obtain abnormal analysis results when using the cerebral blood flow analysis function.

Code information

Item number TSX-301 A/2D Serial Numbers: 2DA0792004, 2DA07X2005, 2DA07Y2010, 2DA0792002, 2DA07X2008, 2DA0842023.

Distribution pattern

Nationwide distribution: USA including states of: MA, MD, and NV.