Alphenix INFX-8000H — Class II medical device recall Z-1178-2026
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-1178-2026 |
|---|---|
| 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 | 3 units |
| Serial numbers | A2A20Z2165, B2A1692426, D2A1672385 |
Product
Alphenix INFX-8000H, 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-1178-2026. 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.