Z-0015-2016Class II

Toshiba Aquilion CT System TSX-301B

Name: Z-0015-2016 Toshiba Aquilion CT System TSX-301B
Creator: Toshiba American Medical Systems Inc
Published: 2015-05-08
License: https://open.fda.gov/license/

Canon Medical Systems USA, Inc. / initiated 2015-05-08 / Terminated

FDA source

Toshiba American Medical Systems Inc began a recall of Toshiba Aquilion CT System TSX-301B on 2015-05-08. FDA classified it as Class II and gives the reason as "If two specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0015-2016
Classification: Class II
Status: Terminated
Initiated: 2015-05-08
Posted: 2015-10-09
Terminated: 2016-10-26
Recalling firm: Canon Medical Systems USA, Inc.
Product: Toshiba Aquilion CT System TSX-301B
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: If two specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved.
FDA root cause: Radiation Control for Health and Safety Act
Action: Toshiba America Medical Planned Action to bring defect into Compliance: a. A notification will be sent to all consignees with affected systems in compliance with 21 CFR1 003.21 upon approval by the Secretary. b. To correct this issue revised software will be installed on each system to prevent this occurrence from happening. Each consignee will be contacted by their Toshiba service representative for an appointment when the revised software becomes available. c. Each consignee will be advised to do the following until the corrective measures have been taken, i.e., revised software installed on their systems. CDRH approves the CAP subject to the following conditions: 1. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. 2. Toshiba America Medical Systems, Inc. will implement this CAP by February 1, 2016. If you have any questions please contact your local Toshiba Representative at (800) 521-1968.
Quantity in commerce: 459
Distribution: US Distribution including Puerto Rico
Product codes and lots: system software V6.0 or later

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0015-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0013-2016	Class II	Terminated	Voluntary: Firm initiated	2015-10-21	2015-10-09
Z-0014-2016	Class II	Terminated	Voluntary: Firm initiated	2015-10-21	2015-10-09
Z-0015-2016	Class II	Terminated	Voluntary: Firm initiated	2015-10-21	2015-10-09
Z-0016-2016	Class II	Terminated	Voluntary: Firm initiated	2015-10-21	2015-10-09
Z-0017-2016	Class II	Terminated	Voluntary: Firm initiated	2015-10-21	2015-10-09
Z-0018-2016	Class II	Terminated	Voluntary: Firm initiated	2015-10-21	2015-10-09

Product code JAK

K120546Class IIAquilion PremiumToshiba Medical Systems Corporation, Japan / cleared 2012-06-13

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)