Z-2895-2011

Aquilion One: Aquilion TSX-301A, 64 System, X-Ray, Tomography. Toshiba American Medical Systems, Inc. A...

Name: Z-2895-2011 Aquilion One: Aquilion TSX-301A, 64 System, X-Ray, Tomography. Toshiba American Medical Systems, Inc. A...
Creator: Toshiba American Medical Systems Inc
Published: 2011-01-07
License: https://open.fda.gov/license/

Canon Medical Systems USA, Inc. / initiated 2011-01-07 / Terminated / root cause: software

FDA source

Toshiba American Medical Systems Inc began a recall of Aquilion One: Aquilion TSX-301A, 64 System, X-Ray, Tomography. Toshiba American Medical Systems, Inc. A multislice CT system that supports whole-body scanning on 2011-01-07. The reason FDA records is "Toshiba America Medical Systems (TAMS) is initiating a field correction for the TSX-301A and TSX-301B: Aquilion 64 System, X-Ray, Tomography because communication between reconstruction units in the system console may...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2895-2011
Status: Terminated
Initiated: 2011-01-07
Posted: 2011-07-29
Terminated: 2012-08-17
Recalling firm: Canon Medical Systems USA, Inc.
Product: Aquilion One: Aquilion TSX-301A, 64 System, X-Ray, Tomography. Toshiba American Medical Systems, Inc. A multislice CT system that supports whole-body scanning.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: Toshiba America Medical Systems (TAMS) is initiating a field correction for the TSX-301A and TSX-301B: Aquilion 64 System, X-Ray, Tomography because communication between reconstruction units in the system console may be broken due to failure of the optical conversion connector, resulting in a break of communication between units.
Root cause tag: software
FDA root cause: Software design
Action: Toshiba America Medical Systems, Inc. sent an "Urgent Medical Device Correction" letter dated January 4, 2011 to all affected customers. The letter provides the customers with an explanation of the problem and the firms plan to install preventive measures and provided them with a Customer Reply form to send Toshiba. A representative will contact the customers for an appointment to install the measures to their CT system. For question on this recall call (800) 421-1968 or contact your local Toshiba Representative at (800) 521-1968.
Quantity in commerce: 6
Distribution: (USA) Nationwide Distribution including the states of WI, MO, TN, IA, AL, AZ, TX, and GA.
Product codes and lots: 2DA1062208, 2DA107221, 2DA1072212, 2DB1082219, 2DB1082220, 2DB1082222

Product code JAK

K083282Class IIModel Tsx-301B Aquilion CT SystemToshiba America Medical Systems, In.C / cleared 2008-12-12

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)