Alphenix INFX-8000F — Class II medical device recall Z-1177-2026
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-1177-2026 |
|---|---|
| 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 | 98 units |
| Serial numbers | A1C1972103, A1C1992146, A1C19Y2161, A1C19Z2180, A1C19Z2181, A2A2012005, A2A2032031, A2A2042041, A2A2052056, A2A2062062, A2A2072075, A2A20Y2147, A2A20Z2159, A2A2172283, A2A21X2348, A2A21Y2350, A2A2252435, A2A2272460, A2A2292508, A2A2362689, A3582035, A3592048, A4542088, A4552098, B2A1482027 and 73 more |
Product
Alphenix INFX-8000F, 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
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1177-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
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.