Z-1068-2013Class II

Toshiba TSX-30IC AQUlLlON ONE System, Computed Tomography X-Ray. This system supports Whole body scanning

Name: Z-1068-2013 Toshiba TSX-30IC AQUlLlON ONE System, Computed Tomography X-Ray. This system supports Whole body scanning
Creator: Toshiba American Medical Systems Inc
Published: 2012-11-14
License: https://open.fda.gov/license/

Canon Medical Systems USA, Inc. / initiated 2012-11-14 / Terminated / root cause: manufacturing process

FDA source

Toshiba American Medical Systems Inc began a recall of Toshiba TSX-30IC AQUlLlON ONE System, Computed Tomography X-Ray. This system supports Whole body scanning on 2012-11-14. FDA classified it as Class II and gives the reason as "Due to a problem with the control software of the x-ray high-voltage generator, if scanning is performed with a tube current less than 30mA, the control software may detect an error and perform error processing even...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1068-2013
Classification: Class II
Status: Terminated
Initiated: 2012-11-14
Posted: 2013-04-08
Terminated: 2013-04-08
Recalling firm: Canon Medical Systems USA, Inc.
Product: Toshiba TSX-30IC AQUlLlON ONE System, Computed Tomography X-Ray. This system supports Whole body scanning.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: Due to a problem with the control software of the x-ray high-voltage generator, if scanning is performed with a tube current less than 30mA, the control software may detect an error and perform error processing even though the x-ray output is normal.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: Toshiba American Medical Systems Inc. sent a Urgent Medical Device Correction letter dated November 14, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customer was informed a New software to prevent the occurrence of this issue will be installed on your system. Toshiba Service Representative will contact you for an appointment to install the New Software on your Aquilion One System. Please fax the return reply form to (877) 349-3054. We thank you for your urgent attention to this matter. If you have any further questions regarding this letter please call (800) 521-1968.
Quantity in commerce: 1 unit
Distribution: Distributed in the state of MD.
Product codes and lots: Serial No: 1CB1262006

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1068-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1068-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-17	2013-04-08

Product code JAK

K122109Class IIAquilion One Vision, V4.90Toshiba America Medical Systems, In.C / cleared 2012-09-21

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)