Lower riskMedical device recall · FDA · Published November 9, 2020
Canon Aquilion Prime SP CT Scanner Software Issue May Cause Failed Scans
Canon recalls Aquilion Prime SP CT scanners with serial numbers listed for a software problem that may cause scans to fail, requiring rescanning and contrast reinjection.
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.
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Contact the company
📍Recalling firmCanon Medical System, USA, INC.2441 Michelle Dr · Tustin, CA 92780-7047
✎ GovInfoNow plain-language explainer
Canon is recalling certain Aquilion Prime SP CT scanners due to a software issue that can cause scans to fail, leading to rescanning and reinjection of contrast dye. This could result in unnecessary radiation exposure and additional costs for patients. Read more at govinfonow.com/recall/63957-canon-aquilion-prime-sp-ct-scanner-software-issue-may-cause.
“Canon Aquilion Prime SP CT Scanner Software Issue May Cause Failed Scans.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63957-canon-aquilion-prime-sp-ct-scanner-software-issue-may-cause. Based on FDA recall #Z-0549-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0549-2021%22&limit=1).
The FDA announced on Nov. 9, 2020, that Canon Medical System, USA, INC. is recalling the Canon Aquilion Prime SP CT Scanner due to a software problem that may prevent scans from proceeding. The agency issued recall number Z-0549-2021 for the Class II device.
How to tell if you have it
Brand: Canon
Product: Canon Aquilion Prime SP, Multislice Helical CT Scanner, TSX-303B/8L
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.
Context
GovInfoNow's records show Canon Medical System, USA, INC. has had 27 other recalls on record since April 18, 2018. Other recent recalls of similar products include the Canon Alphenix INFX-8000C/B5 Recall dated Aug. 26, 2026, and the Canon Alphenix X-ray Systems Recall dated Aug. 4, 2026.
How to tell if you have this one
Check the serial number on your Canon Aquilion Prime SP CT scanner. The affected models have serial numbers listed in the recall notice, such as 8LA2052063 or 8LA19Z2034.
Brand
Canon
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Serial Number
Identify the serial number on your scanner to confirm if it's in the list of affected units provided in the recall notice.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide distribution. OUS: Unknown” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.1 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0549-2021 (November 9, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0549-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.