Z-1707-2008

Toshiba America Medical Systems (TAMS) Aquilion 32 CT system, computed tomography x-ray system

Name: Z-1707-2008 Toshiba America Medical Systems (TAMS) Aquilion 32 CT system, computed tomography x-ray system
Creator: Toshiba American Med Sys Inc
Published: 2007-10-01
License: https://open.fda.gov/license/

Canon Medical Systems USA, Inc. / initiated 2007-10-01 / Terminated / root cause: design

FDA source

Toshiba American Med Sys Inc began a recall of Toshiba America Medical Systems (TAMS) Aquilion 32 CT system, computed tomography x-ray system on 2007-10-01. The reason FDA records is "Excessive radiation: Intermittent shifting of CT numbers causes the actual dose to the patient to be greater than expected, when Sure Exposure option is used". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1707-2008
Status: Terminated
Initiated: 2007-10-01
Posted: 2008-09-29
Terminated: 2012-07-16
Recalling firm: Canon Medical Systems USA, Inc.
Product: Toshiba America Medical Systems (TAMS) Aquilion 32 CT system, computed tomography x-ray system.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: Excessive radiation: Intermittent shifting of CT numbers causes the actual dose to the patient to be greater than expected, when Sure Exposure option is used.
Root cause tag: design
FDA root cause: Device Design
Action: Toshiba sent a letter to customers in July 2007, and sent field service representatives to update the Data Aquisition System in September/October 2007.
Quantity in commerce: 1203 total
Distribution: Worldwide distribution, including USA and Japan.
Product codes and lots: All codes

Product code JAK

K982265Class IIAquilion CT Scanner, Model Tsx-101AToshiba America Medical Systems, In.C / cleared 1998-08-26

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)