RecallRadar

FDA Device recall Z-0972-2014

TSX-301C Aquilion One (Vision Edition) Computed Tomography X-Ray System

On 2014-03-12 the FDA classified a Class II recall of TSX-301C Aquilion One (Vision Edition) Computed Tomography X-Ray System by Toshiba American Medical Systems, citing toshiba America Medical Systems, Inc. initiated this recall due to the failure of the parts used in the X-ray high-voltage generator. In some cases, X-ray exposure cannot be perfo….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0972-2014
ClassificationClass II
Statusterminated
Initiated2013-12-11
Published2014-03-12
Last updated2026-09-13 11:53 UTC
CompanyToshiba American Medical Systems
DistributionCA, IN, MD, MN, NY, OH, WI, WV

Product

TSX-301C Aquilion One (Vision Edition) Computed Tomography X-Ray System.

Reason

Toshiba America Medical Systems, Inc. initiated this recall due to the failure of the parts used in the X-ray high-voltage generator. In some cases, X-ray exposure cannot be performed.

Identifiers

code_infoSERIAL NO.: 1CB1262006, 1DB1312033, 1DC1352070, 1DB1342060, 1DB1332049, 1DC1382081, 1DB1312027, 1DB1332045, 1DC1362073, 1CB12X2018.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0972-2014%22

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