FDA DevicesClass II
Alphenix INFX-8000H, interventional fluoroscopic x-ray system
Published: February 4, 2026Recall ID: Z-1178-2026Category: devicesCountry: US
Reason for Recall / Hazard
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
Product Description & Identification
Alphenix INFX-8000H, interventional fluoroscopic x-ray system
Additional Source Details
| Field | Value |
|---|---|
| City | Tustin |
| State | CA |
| Event id | 97970 |
| Address 1 | 2441 Michelle Dr |
| Address 2 | N/A |
| Code info | serial numbers: D2A1672385, A2A20Z2165, B2A1692426. |
| Postal code | 92780-7047 |
| Report date | 20260204 |
| Product type | Devices |
| Product quantity | 3 units |
| 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 |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20251219 |
| Initial firm notification | Letter |
| Center classification date | 20260127 |
Overview
- Recalling FirmCanon Medical System, USA, INC.
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide distribution - US Nationwide and the country of Dominican Republic.