Z-0972-2014Class II

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

Name: Z-0972-2014 TSX-301C Aquilion One (Vision Edition) Computed Tomography X-Ray System
Creator: Toshiba American Medical Systems Inc
Published: 2013-12-11
License: https://open.fda.gov/license/

Canon Medical Systems USA, Inc. / initiated 2013-12-11 / Terminated

FDA source

Toshiba American Medical Systems Inc began a recall of TSX-301C Aquilion One (Vision Edition) Computed Tomography X-Ray System on 2013-12-11. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0972-2014
Classification: Class II
Status: Terminated
Initiated: 2013-12-11
Posted: 2014-03-06
Terminated: 2014-10-16
Recalling firm: Canon Medical Systems USA, Inc.
Product: TSX-301C Aquilion One (Vision Edition) Computed Tomography X-Ray System.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: 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.
FDA root cause: Other
Action: Toshiba America Medical Systems, Inc. initiated this recall by sending "Urgent Medical Device Correction," letter dated December 11, 2013, informed customers of the recall by providing, the device name, serial number, problem statement, corrective action statement, and contact information. A customer reply form accompanied the recall notification letter. Strategy: The majority of the letters are sent via USPS return receipt mail. The letter contains a return reply form that is to be faxed to TAMS for retention. After two weeks contact will be made with each non responding location and a copy of the letter will be faxed to that location and the fax receipt will service as proof of notification. Upon release of the new part it will be assigned to a TAMS employee with instructions for implementation at each site. Each incident is assigned a unique task number and each task is tracked through to completion. In the event that a customer refuses the installation of the corrected software/hardware the customer would be requested to sign a service case record stating that the corrected software/hardware was refused. CDRH approves the CAP subject to the following condition: Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. For further questions please call (714) 730-5000.
Quantity in commerce: 8 units
Distribution: US Distribution including the states of: MD, WV, OH, CA, MN, IN, NY and WI.
Product codes and lots: SERIAL NO.: 1CB1262006, 1DB1312033, 1DC1352070, 1DB1342060, 1DB1332049, 1DC1382081, 1DB1312027, 1DB1332045, 1DC1362073, 1CB12X2018.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0972-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0972-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-12	2014-03-06

Product code JAK

K132222Class IIAquilion One Vision, V6.0Toshibamedical Systems Corporation / cleared 2013-11-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)