Z-3196-2011

TSX-301A: AQUILION One; System, X-Ray, Tomography, Computed X-Ray Tomography

Name: Z-3196-2011 TSX-301A: AQUILION One; System, X-Ray, Tomography, Computed X-Ray Tomography
Creator: Toshiba American Medical Systems Inc
Published: 2011-06-22
License: https://open.fda.gov/license/

Canon Medical Systems USA, Inc. / initiated 2011-06-22 / Terminated / root cause: software

FDA source

Toshiba American Medical Systems Inc began a recall of TSX-301A: AQUILION One; System, X-Ray, Tomography, Computed X-Ray Tomography on 2011-06-22. The reason FDA records is "Toshiba America Medical Systems is initiating a field correction on their TSX-301B: AQUILION Premium; System, X-Ray, Tomography, Computed, TSX-301A: AQUILION One; System, X-Ray, Tomography, Computed, TSX-20IA: AQUlLlON...". 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-3196-2011
Status: Terminated
Initiated: 2011-06-22
Posted: 2011-09-13
Terminated: 2014-08-11
Recalling firm: Canon Medical Systems USA, Inc.
Product: TSX-301A: AQUILION One; System, X-Ray, Tomography, Computed X-Ray Tomography
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: Toshiba America Medical Systems is initiating a field correction on their TSX-301B: AQUILION Premium; System, X-Ray, Tomography, Computed, TSX-301A: AQUILION One; System, X-Ray, Tomography, Computed, TSX-20IA: AQUlLlON LB; System, X-Ray, Tomography, Computed, and TSX-1O1A: AQUILION 16; System, X-Ray, Tomography, Computed due to several software issues that cause the scanners to function incorr
Root cause tag: software
FDA root cause: Software design
Action: Toshiba America Medical Systems (TAMS) sent an URGENT MEDICAL DEVICE CORRECTION letter dated June 22, 2011, to all affected customers. Customers were instructed that a revised software to prevent occurrence of the problem would be installed on their system. Their Toshiba Service Representative would contact them for an appointment to install the software to their system when it became available. Customers were requested to take temporary measures until corrective measures were taken. 1) In dual scanoscopy, do not press the short key between the completion of the first scanoscopy and the start of the second scanoscopy. 2) In dual scanoscopy, do not click the (Scano Skip) button immediately before the completion of the first scanoscopy. 3) When the SplitCase function is set to ON, do not select two or more orders simultaneously from the appointment list. 4) When an image comment is to be preset by making a selection from the preset memo, do not select any image comment with more than 10 characters. Customers were asked to share the information with all users and reviewing radiologists as well as clinical engineering or Biomedical group at the facility. Customers were asked to complete and return the attached form and fax it to 877-349-3054. For any questions call (800) 421-1968 or contact your local Toshiba Representative at (800) 521-1968.
Quantity in commerce: 155 units total
Distribution: Nationwide Distribution
Product codes and lots: N/A

Product code JAK

K072606Class IIAquilion One Tsx-301A/2 Computed Tomography SystemToshiba America Medical Systems, In.C / cleared 2007-10-02

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)