Alphenix INFX-8000C — Class II medical device recall Z-1176-2026
Ongoing recall by Canon Medical System, USA, INC., reported 2026-02-04, distributed nationwide. It has been discovered that there is a possibility that the fixing screws of the ceiling movement gear in the
| Recall number | Z-1176-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Canon Medical System, USA, INC., Tustin, CA, United States |
| Recall initiated | 2025-12-19 |
| Classified | 2026-01-27 |
| Reported by FDA | 2026-02-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | DO |
| Quantity | 172 units |
| Serial numbers | A1A2162240, A1B18Y7002, A1C1942058, A1C1942065, A1C1952078, A1C1952080, A1C1972104, A1C1972105, A1C1972111, A1C1972112, A1C1992141, A1C19X2152, A1C19X2158, A1C19Y2174, A1C19Z2178, A1C19Z2182, A1C19Z2188, A1C2042197, A1C2052199, A2A2032038, A2A2052053, A2A2062066, A2A2062070, A2A2072077, A2A2072087 and 147 more |
Product
Alphenix INFX-8000C, interventional fluoroscopic x-ray system
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
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.