Z-1721-2020Class II

Canon Aquilion Premium, Model TSX-301B

Name: Z-1721-2020 Canon Aquilion Premium, Model TSX-301B
Creator: Canon Medical System, USA, INC.
Published: 2019-03-25
License: https://open.fda.gov/license/

Canon Medical Systems USA, Inc. / initiated 2019-03-25 / Open, Classified / root cause: software

FDA source

Canon Medical System, USA, INC. began a recall of Canon Aquilion Premium, Model TSX-301B on 2019-03-25. FDA classified it as Class II and gives the reason as "Scanning may be interrupted due to an error during execution of the eXam Plan and the system is unable to be shut down normally, resulting in the need to forcibly turn the system power off and reboot. Loss of the...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1721-2020
Classification: Class II
Status: Open, Classified
Initiated: 2019-03-25
Posted: 2020-04-10
Recalling firm: Canon Medical Systems USA, Inc.
Product: Canon Aquilion Premium, Model TSX-301B
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: Scanning may be interrupted due to an error during execution of the eXam Plan and the system is unable to be shut down normally, resulting in the need to forcibly turn the system power off and reboot. Loss of the acquired raw data would occur.
Root cause tag: software
FDA root cause: Software design
Action: Recall letters dated 3/25/2019 were issued on 3/25/2019 via USPS return receipt mail.
Quantity in commerce: 2 devices
Distribution: Distribution was made to AK, AR, CA, FL, IA, ID, IL, KS, MA, MD, MI, MN, MO, MT, NC, ND, NH, NY, OH, OK, OR, PA, TN, TX, VT, WA, WI, and WV. There was government and military distribution but no foreign distribution.
Product codes and lots: Canon Aquilion Whole-Body X-Ray CT Scanner, 160-detector row CT, Model TSX-301B - Serial numbers 7CA18Y2002 and 7CA1892001.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1721-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1719-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-04-22	2020-04-16
Z-1720-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-04-22	2020-04-16
Z-1721-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-04-22	2020-04-16
Z-1722-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-04-22	2020-04-16
Z-1723-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-04-22	2020-04-16
Z-1724-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-04-22	2020-04-16
Z-1725-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-04-22	2020-04-16
Z-1726-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-04-22	2020-04-16

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)