Z-3221-2011

TSX-101: Aquilion 32/64; System, X-Ray, Tomography, Computed

Name: Z-3221-2011 TSX-101: Aquilion 32/64; System, X-Ray, Tomography, Computed
Creator: Toshiba American Medical Systems Inc
Published: 2010-12-08
License: https://open.fda.gov/license/

Canon Medical Systems USA, Inc. / initiated 2010-12-08 / Terminated / root cause: software

FDA source

Toshiba American Medical Systems Inc began a recall of TSX-101: Aquilion 32/64; System, X-Ray, Tomography, Computed on 2010-12-08. The reason FDA records is "There is the potential that the current may not be controlled correctly in examinations using the ECG modulation function, which adjusts the x-ray output in synchronization with the ECG waveform". 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-3221-2011
Status: Terminated
Initiated: 2010-12-08
Posted: 2011-09-16
Terminated: 2013-03-18
Recalling firm: Canon Medical Systems USA, Inc.
Product: TSX-101: Aquilion 32/64; System, X-Ray, Tomography, Computed.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: There is the potential that the current may not be controlled correctly in examinations using the ECG modulation function, which adjusts the x-ray output in synchronization with the ECG waveform.
Root cause tag: software
FDA root cause: Software design
Action: Toshiba America Medical Systems (TAMS) issued an Urgent: Medical Device Correction notification to consignees via USPS return receipt mail. The letter identified the affected product, the problem, and corrective action. The firm plans to install revised firmware to prevent the occurrence of the problem. A Toshiba Service Representative will contact customers to schedule an appointment for installation. The firm asked customers to stop using the Power Reduction option during ECG modulated scanning until the new firmware has been installed. Customers are to share the information in the letter with all users, reviewing radiologist, and the clinical engineering or Biomedical group at their facility. Customers are also to complete and return the attached reply form via fax or e-mail to TAMS as proof of notification. Questions pertaining to the letter should be directed to 800-421-1968 or customers' local Toshiba Representative at 800-521-1968.
Quantity in commerce: 528 units
Distribution: Nationwide Distribution.
Product codes and lots: Units manufactured from January 2005 to September 2007

Product code JAK

K080211Class IIModel Tsx-101A/h/i Aquilion 32/64 Sp CT SystemToshiba America Medical Systems, In.C / cleared 2008-03-14

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)