Canon Medical recalls one Alphenix INFX-8000C/B5 device (serial B5F2532011/UDI 4987670100192) due to risk of tabletop shifting causing imaging errors. Stop using immediately.
Loosening of the bolts securing the longitudinal movement mechanism may cause the tabletop to shift, resulting in [positional/imaging/patient] misalignment and a longitudinal motion error
“Canon Alphenix INFX-8000C/B5 Recall: Tabletop Shift Risk.” GovInfoNow, updated October 21, 2026. https://govinfonow.com/recall/1629474-canon-medical-system-usa-inc-recalls-alphenix-infx-8000c-b5. Based on FDA recall #Z-0108-2027 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0108-2027%22&limit=1).
The FDA announced on August 26, 2026, that Canon Medical System, USA, INC. is voluntarily recalling one Alphenix INFX-8000C/B5 unit due to a Class II hazard. The bolts securing the longitudinal movement mechanism may loosen, causing the tabletop to shift and resulting in positional or imaging misalignment.
How to tell if you have it
Brand: Canon Medical
Product: Alphenix INFX-8000C/B5
Serial no.: B5F2532011
UDI: 4987670100192
The hazard
The loosening of the bolts securing the longitudinal movement mechanism may cause the tabletop to shift. This shift can result in positional, imaging, or patient misalignment and a longitudinal motion error.
Context
GovInfoNow's records show Canon Medical System, USA, INC. has issued 27 other recalls since April 18, 2018. Other recent recalls of similar products include the Canon Alphenix X-ray Systems Recall (2026-08-04), the Canon Alphenix INFX-8000V X-ray System Recall (2025-12-19), and the Canon Vantage Titan 3T MRI Systems Recall (2025-12-19). Other recent recalls of similar products include the Philips Azurion 7 B20 System Recall (2026-01-26), the Philips Azurion 5 M12 System Software Recalls (2026-01-26), and the Philips Azurion 3 M15 System Recall (2026-01-26).
How to tell if you have this one
Check for serial number B5F2532011 or UDI 4987670100192 on the device. The Alphenix INFX-8000C/B5 was distributed nationwide in Idaho.
Brand
Canon Medical
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Stop Using Immediately
The recalled device must be stopped from use to prevent imaging errors.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide distribution in the state of ID.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 49 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4Added to GovInfoNow
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-0108-2027 (August 26, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0108-2027 to see it in context.
Plain-language summary written by qwen3:4b on October 21, 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.