CLASS II Device recall · Reported 3 Oct 2012 · FDA Enforcement Report

TSX-301A/2 Aquilion One CT System recalled by Toshiba American Medical

Toshiba American Medical Systems is recalling TSX-301A/2 Aquilion One CT System, distributed nationwide in the US. The recall was initiated on 13 May 2008 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesItem number TSX-301 A/2D Serial Numbers: 2DA0792004, 2DA07X2005, 2DA07Y2010, 2DA0792002, 2DA07X2008, 2DA0842023.

Quantity recalled3 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2468-2012
FDA event ID: 63166
Recalling firm: Toshiba American Medical Systems, Tustin, CA
Classification: Class II
Status: Terminated
Recall initiated: 13 May 2008
FDA classified: 27 Sep 2012
Reported: 3 Oct 2012
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Imaging Equipment

Timeline

13 May 2008	Recall initiated by company
27 Sep 2012	Classified by FDA	+1598 days
3 Oct 2012	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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.

Where it was distributed

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

Nationwide Massachusetts Maryland Nevada

Questions about this recall

Why was it recalled?

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.

Which lots are affected?

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

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Toshiba American Medical Systems

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4 Jul 2018Device	CLASS II	Diagnostic Ultrasound System, Aplio I-series recalled	Toshiba American Medical Systems	Device Malfunction	Nationwide
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