Alphenix INFX-8000V — Class II medical device recall Z-1179-2026
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-1179-2026 |
|---|---|
| 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 | 332 units |
| Serial numbers | A1C1982123, A2A20Z2167, A2A2152263, A2A2152264, A2A21X2345, A2A2242418, A2A2262450, A2A22Z2576, A2A2382741, A2A2412831, B2A1472002, B2A1522117, B2A15X2238, B2A1692413, B2A1792589, B2A17Z2627, D4W1262257, E0514103, W1B08X2042, W1C0552181, W1D0842501, W1D0892543, W2A1062134, W2A1072139, W4A10X2001 and 11 more |
Product
Alphenix INFX-8000V, 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.