Use caution Medical device recall · FDA · Published June 22, 2023

Canon Medical INFX-8000C Table Side Consoles Recall: C-arm Function Risk

Canon Medical recalls INFX-8000C XGCP-930AA and XGCP-930BA table side consoles due to potential c-arm malfunction. The console's PWB may need replacement to prevent procedure delays.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2392-2023Medical device Canon Medical ›

Use caution until it’s fixed

The C-arm, used to set the position and angle of the x-ray exposure field, may not function due to the tableside console PWB, which needs replacement. There may be a delay in the procedure, but procedures can continue using the operators console, the switches on the back of the column, switches on the side of the flat panel detector, and the emergency stop will continue to function normally.

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 two specific table side consoles for their X-ray systems. The issue involves the tableside console's PWB (printed wiring board) potentially failing, which could cause delays in procedures but does not stop the X-ray system from working through other controls. Read more at govinfonow.com/recall/57823-canon-medical-infx-8000c-table-side-consoles-recall-c-arm.

Source Summary by GovInfoNow · govinfonow.com/recall/57823-canon-medical-infx-8000c-table-side-consoles-recall-c-arm · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2392-2023

Cite this page

“Canon Medical INFX-8000C Table Side Consoles Recall: C-arm Function Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57823-canon-medical-infx-8000c-table-side-consoles-recall-c-arm. Based on FDA recall #Z-2392-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2392-2023%22&limit=1).

The FDA announced on June 22, 2023, that Canon Medical System, USA, INC. is recalling specific table side consoles for INFX-8000C X-ray systems due to a potential functional failure of the C-arm positioning mechanism. The agency issued recall number Z-2392-2023 regarding this voluntary Class II action.

How to tell if you have it

Brand: Canon Medical
Product: INFX-8000C XGCP-930AA TABLE SIDE CONSOLE, Serial Numbers: BHA1992001, BHB2132003, SWC2242002, AFB1832003, SUC2262008, SUC2292010, BFB1972004, SUB2172002, SWC2262003
Product: INFX-8000C XGCP-930BA TABLE SIDE CONSOLE, Serial Numbers: BHA1992001, BHB2132003, SWC2242002, AFB1832003, SUC2262008, SUC2292010, BFB1972004, SUB2172002, SWC2262003
UDI-DI: 04987670100192

The hazard

According to the FDA, the tableside console PWB may fail, causing the C-arm used to set the position and angle of the x-ray exposure field not to function. The record states that procedures can continue using alternative controls and that the emergency stop will continue to function normally.

Context

GovInfoNow's records show Canon Medical System, USA, INC. has issued 26 other recalls since April 18, 2018. Recent similar product recalls include a Philips ALLURA Xper FD20 Biplane/Table recall on March 3, 2026, and a Philips Allura Xper FD20/20 OR Table recall on March 3, 2026, both involving x-ray imaging start issues. Other recent recalls include a GE Optima XR240amx Mobile X-Ray System recall on June 5, 2026, regarding column safety failure risk.

How to tell if you have this one

Check for the INFX-8000C XGCP-930AA or XGCP-930BA table side consoles with serial numbers listed in the recall notice. The UDI-DI code 04987670100192 identifies the affected units.

Brand
Canon Medical
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Console Serial Numbers
Identify the console's serial numbers from the list provided in the recall notice: BHA1992001, BHB2132003, SWC2242002, AFB1832003, SUC2262008, SUC2292010, BFB1972004, SUB2172002, SWC2262003.
Contact Canon Support
Reach out to Canon Medical System, USA, INC. for guidance on the replacement of the PWB if needed.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 7 states.

FDA distribution: “US Nationwide Distribution: NY, CO, IL, CA, MD, MN, WA” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: California, Colorado, Illinois, Maryland, Minnesota, New York, Washington.

Recall timeline

FDA published this recall 55 days after the firm started it.

Jun 22, 2023Firm started the recall
Aug 10, 2023FDA classified it Class II
Aug 16, 2023Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/57823-canon-medical-infx-8000c-table-side-consoles-recall-c-arm">Canon Medical INFX-8000C Table Side Consoles Recall: C-arm Function Risk (GovInfoNow)</a>

Where this comes from

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-2392-2023 (June 22, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2392-2023 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.