CLASS II Device recall · Reported 21 Oct 2015 · FDA Enforcement Report

Toshiba Aquilion CT System TSX-101A recalled by Toshiba American Medical

Toshiba American Medical Systems is recalling Toshiba Aquilion CT System TSX-101A, distributed in Puerto Rico. The recall was initiated on 8 May 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codessystem software V6.0 or later
Quantity recalled459

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-0013-2016
FDA event ID
71923
Recalling firm
Toshiba American Medical Systems, Tustin, CA
Classification
Class II
Status
Terminated
Recall initiated
8 May 2015
FDA classified
9 Oct 2015
Reported
21 Oct 2015
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Device Malfunction

Timeline

8 May 2015Recall initiated by company
9 Oct 2015Classified by FDA+154 days
21 Oct 2015Published in enforcement report+12 days

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

Reason for recall

If two specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved.

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

Toshiba Aquilion CT System TSX-101A

Where it was distributed

US Distribution including Puerto Rico

Puerto Rico

Questions about this recall

Is Toshiba Aquilion CT System TSX-101A recalled?

Yes. Toshiba American Medical Systems recalled Toshiba Aquilion CT System TSX-101A on 8 May 2015. The recall is Class II and its status is Terminated. Recall number Z-0013-2016.

Why was it recalled?

If two specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved.

Which lots are affected?

system software V6.0 or later

Where was it sold?

US Distribution including Puerto Rico

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

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