Alphenix INFX-8000H, interventional fluoroscopic x-ray system
FDA Recall Z-1178-2026 · Posted 2026-01-27
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Recalling FirmCanon Medical System, USA, INC.
Recall StatusOpen, Classified
Product CodeOWB
Date Initiated2025-12-19
Product Quantity3 units
Reason for Recall
It has been discovered that there is a possibility that the fixing screws of the ceiling movement gear in the ceiling suspended arm that are part of the X-ray interventional
systems may become loose. As a result, ceiling lateral movement may no longer be possible, abnormal noise may be generated from the suspension system and a sensor error may be displayed
Firm Action
Canon Medical Systems USA issued an URGENT: MEDICAL DEVICE CORRECTION notice to its consignees on 12/19/2025 via letter. The notice explained the issue, risk to health, and requested the following:
"Request to customers:
Should the suspended device make an abnormal noise, or a sensor error is displayed
before the corrective action is implemented on your system, please stop using the device
and call your local Canon Service Team.
Additionally, it is strongly requested that you share the contents of this letter with all
users as well as clinical engineering or biomedical group at your facility.
If you have any questions regarding this matter, please contact your service
representative or contact our InTouch team at [email protected]."
Root Cause
Process design
Distribution Pattern
Worldwide distribution - US Nationwide and the country of Dominican Republic.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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