Use cautionMedical device recall · FDA · Published May 3, 2022
Canon Alphenix 4D CT with CAS-930A C Arm Support: CT System May Stop After Error Message
Canon Medical recalls Alphenix 4D CT systems with specific model numbers and C arm supports due to potential system errors causing CT operations to stop after error messages are canceled.
CT operation may be restricted by an interlock which is a result of an system error and the CT system may stop operating properly after an attempt to cancel the error message has been initiated.
Take action
Contact the company
📍Recalling firmCanon Medical System, USA, INC.2441 Michelle Dr · Tustin, CA 92780-7047
✎ GovInfoNow plain-language explainer
Canon Medical is recalling Alphenix 4D CT systems paired with CAS-930A C arm supports that have specific model numbers. The system may stop working properly after users try to cancel an error message, which could disrupt medical imaging procedures. Read more at govinfonow.com/recall/60732-canon-alphenix-4d-ct-with-cas-930a-c-arm-support.
“Canon Alphenix 4D CT with CAS-930A C Arm Support: CT System May Stop After Error Message.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60732-canon-alphenix-4d-ct-with-cas-930a-c-arm-support. Based on FDA recall #Z-1289-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1289-2022%22&limit=1).
The FDA announced on May 3, 2022, that Canon Medical System, USA, INC. is recalling Alphenix 4D CT systems in combination with CAS-930A C-arm supports due to a system error that may restrict CT operation or cause the system to stop working properly after an error message cancellation attempt.
How to tell if you have it
Brand: Canon Medical
Product: Alphenix 4D CT in combination with CAS-930A (C arm Support)
Model Numbers: INFX-8000C/BF, INFX-8000C/BH, INFX-8000C/SW
UDI-DI Code: 04987670100192
Units affected: 6 systems
The hazard
According to the FDA, a system error may restrict CT operation via an interlock, and the CT system may stop operating properly after an attempt to cancel the error message has been initiated.
Context
GovInfoNow's records show Canon Medical System, USA, INC. has 26 other recalls on record since April 18, 2018. Other recent recalls of similar products include Canon Alphenix X-ray Systems Recall: Loose Fixing Screws Risk Equipment Failure (Aug. 4, 2026), Canon Alphenix INFX-8000V X-ray System Recall: Ceiling Movement Gear Screws May Become Loose (Dec. 19, 2025), and Canon Vantage Titan 3T MRI Systems Recall: Ice Risk in Venting System (Dec. 19, 2025). Other recent recalls of similar products include Philips Achieva 3.0T MRI Recalled: Software Issue May Terminate Scans (Aug. 21, 2026), Philips Brilliance CT 64 Medical Scanner Recall: Unintended Radiation Risk (Aug. 7, 2026), and Philips Allura Cardio Vascular-Allura Centron X-Ray System Recall: Unauthorized Hard Drives Cause Imaging Failure (June 17, 2026).
How to tell if you have this one
Check for model numbers INFX-8000C/BF, INFX-8000C/BH, or INFX-8000C/SW on the system. Serial numbers or SID codes listed in the recall notice also identify affected units.
Brand
Canon Medical
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check System Status
Verify if the CT system stops working after canceling an error message.
Where it went and when
Where it was distributed
Distributed in 5 states.
Listed by the agency
Not listed
FDA distribution: “U.S.: CA, CO, FL, NY, and WY O.U.S.: None” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Colorado, Florida, New York, Wyoming.
Recall timeline
FDA published this recall 2 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
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-1289-2022 (May 3, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1289-2022 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.