FDA Device recall Z-1178-2026
Alphenix INFX-8000H, interventional fluoroscopic x-ray system
- FDA Device
- Class II
- ongoing
- Published 2026-02-04
On 2026-02-04 the FDA classified a Class II recall of Alphenix INFX-8000H, interventional fluoroscopic x-ray system by Canon Medical System Usa, citing 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 syste….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1178-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-12-19 |
| Published | 2026-02-04 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Canon Medical System Usa |
| Distribution | US |
Product
Alphenix INFX-8000H, interventional fluoroscopic x-ray system
Reason
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
Identifiers
| code_info | serial numbers: D2A1672385, A2A20Z2165, B2A1692426. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1178-2026%22
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