Alphenix INFX-8000C, interventional fluoroscopic x-ray system
FDA device recall Z-1176-2026 · posted 2026-01-27 · Open, Classified
Recall details
- Recalling firm
- Canon Medical System, USA, INC.
- 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
- Action taken
- 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 intouchdispatch@us.medical.canon."
- Root cause
- Process design
- Status
- Open, Classified
- Product code
- OWB
- Quantity affected
- 172 units
- Distribution
- Worldwide distribution - US Nationwide and the country of Dominican Republic.
- Date initiated
- 2025-12-19
- Date posted
- 2026-01-27
- Location
- Tustin, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2 (K210900) | Canon Medical Systems Corporation | 2021-04-12 |