Z-0549-2021Class II

Canon Aquilion Prime SP, Multislice Helical CT Scanner, TSX-303B/8L -

Name: Z-0549-2021 Canon Aquilion Prime SP, Multislice Helical CT Scanner, TSX-303B/8L -
Creator: Canon Medical System, USA, INC.
Published: 2020-11-09
License: https://open.fda.gov/license/

Canon Medical Systems USA, Inc. / initiated 2020-11-09 / Terminated / root cause: software

FDA source

Canon Medical System, USA, INC. began a recall of Canon Aquilion Prime SP, Multislice Helical CT Scanner, TSX-303B/8L - Product Usage: intended to acquire and display cross-sectional volumes of the whole body... on 2020-11-09. FDA classified it as Class II and gives the reason as "A software problem has been identified which could result in the CT Scanner not proceeding to the next actual scan even though automatic start of the next scan is specified. This could result in the CT scan failing...". 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-0549-2021
Classification: Class II
Status: Terminated
Initiated: 2020-11-09
Posted: 2020-12-09
Terminated: 2022-12-16
Recalling firm: Canon Medical Systems USA, Inc.
Product: Canon Aquilion Prime SP, Multislice Helical CT Scanner, TSX-303B/8L - Product Usage: intended to acquire and display cross-sectional volumes of the whole body, including the head.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: A software problem has been identified which could result in the CT Scanner not proceeding to the next actual scan even though automatic start of the next scan is specified. This could result in the CT scan failing resulting in rescanning and reinjection of contrast medium.
Root cause tag: software
FDA root cause: Software design
Action: On 11/9/2020, Canon issued a "Urgent: Medical Device Correction" letter to all affected customers via facsimile. In addition, to informing consignees about the recall, the firm ask affected consignees to take the following actions: 1. Until corrective action has been taken, in order to avoid the problem, please use the system with setting InstaView OFF according to the last notification (dated June 2020) Subject: Abnormality in Realtime Reconstruction Images. Please see Attachment A. 2. Please share this information with all users and reviewing radiologists as well as the clinical engineering or biomedical group at your facility. 3. If you have any questions, please feel free to contact Terry Schultz Regulatory Affairs Manager at (800) 421-1968 or your local Canon service representative at (800) 521-1968.
Quantity in commerce: 60 units
Distribution: US Nationwide distribution. OUS: Unknown
Product codes and lots: Serial Numbers: 8LA2052063, 8LA19Z2034 , 8LA19X2004, 8LA19Z2027, 8LA19Z2029, 8LA2052062, 8LA2042055, 8LA19Z2032, 8OA2052059, 8LA2042051, 8LA2032044, 8LA19X2002, 1LB1922175, 8LA2042050, 8LA19X2007, 8LA2012037, 8LA19Y2021, 8LA19Y2014, 8LA2042056, 8LA19Z2023, 8LA2052067, 8LA19Z2031, 8LA19Y2019, 8LA19Z2030, 8OA19Y2013, 8LA19Z2028, 8LA19Y2012, 8LA19Y2020, 8LA2032042, 8LA2052066, 8LA19X2003, 8LA19Y2022, 8LA19X2008, 8LA2042047, 8LA19Z2024, 8LA2032046, 8LA19Z2033, 8OA2042053, 8LA2012036, 8LA2042054, 8LA19Z2025, 8LA19Z2026, 8LA2022041, 8LA19X2010, 8LA2032043, 8OA19X2001, 8OA2052061, 8OA2042049, 8LA19Y2016, 8LA2022039, 8LA19Y2015, 8LA2012035, 8LA2032045, 8LA19Y2018, 8LA19X2005, 8LA19X2006, 8LA19X2009, 8LA19Y2011, 8LA19Y2017, 8LA2012038, 8LA2052060, 8LA2052058 , 8LA2052064, 8LA2052065, 8LA2052068, 8LA2022040, 8OA2042052, 8LA2042048, 8LA2052057

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0549-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0549-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-16	2020-12-09

Product code JAK

K192832Class IIAquilion Prime SP (TSX-303B8) V10.2 with AiCE-iCanon Medical Systems Corporation / cleared 2020-02-21

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)