Alphenix Models INFX-8000C INFX-8000F INFX-8000V This device is a… — Class II medical device recall Z-3014-2026
Ongoing recall by Canon Medical System, USA, INC., reported 2026-09-02, distributed nationwide. Due to the fixing screws of ceiling movement gear in ceiling suspended arm that are part of the X-ray interven
| Recall number | Z-3014-2026 |
|---|---|
| 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 | 2026-08-04 |
| Classified | 2026-08-25 |
| Reported by FDA | 2026-09-02 |
| Distributed | Nationwide (US) |
| Quantity | 10 systems |
| Serial numbers | 30097052, 30100053, 79000002, B3E2422005, B9F2412001, SGC2412001, STA2412001, SXA2432001SID, SXA2432002, SZA2422001SID, SZA2422002, SZA2432003SID, SZA2442004 |
| Model numbers | INFX-8000C, INFX-8000C/B3, INFX-8000F, INFX-8000F/SG, INFX-8000V, INFX-8000V/B9, INFX-8000V/ST, INFX-8000V/SX, INFX-8000V/SZ |
Product
Alphenix Models INFX-8000C INFX-8000F INFX-8000V This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.
Reason for recall
Due to the fixing screws of ceiling movement gear in ceiling suspended arm that are part of the X-ray interventional systems may become loose.
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-3014-2026. 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.