FDA DevicesClass II
Alphenix INFX-8000F, interventional fluoroscopic x-ray system
Published: February 4, 2026Recall ID: Z-1177-2026Category: 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-8000F, 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: W1C0582204, B2A1582208, W2A1052118, A3582035, A2A2362689, B2B18Y2813, W1D07Y2447, B4582113, W2A1042111, W1C0622270, A3592048, W4A11X2138, W2A09Y2060, B2A16Z2476, W2A09Y2066, W4A1122041, B2A1482032, B2A1482027, A2A2252435, W1D0722369, B2B15Y2247, W1B0542168, B2A1492049, W1D0722371, A2A2032031, A1C1972103, W4C1352375, B2B1862737, W1D0842499, W4A1212179, W4A11Z2171, W4A11Z2173, W1C0652298, B2A1692419, B2A1552170, A2A21Y2350, W4A1242226, B2B1952848, A1C19Z2180, B2A1662371, W1D0892555, W1D0822476, W1D06Z2356, B2A1682394, B2A17Y2619, B2A17Y2624, W1D0762406, A2A2172283, W4A11Y2155, A2A2272460, W1D0832487, B2B1822667, A1C1992146, W4A1112031, W4C1382409, A2A2292508, W4A13X2015, W4A1192130, B2A1712510, B2A1762562, W4A1142066, W1C0622274, A4552098, W4A12X2298, W1D0812460, A4542088, W1D0712363, A2A21X2348, W1C0552179, W4A1142065, B2A17Z2626, W4D13Y2444, W2A1042110, A2A20Z2159, W4A11Y2147, W1C0642289, B2B1852720, B2A1592219, W4B13Y2016, B2B1922843, B2B1822668, W4B12Y2312, A2A205205... [TRUNCATED] |
| Postal code | 92780-7047 |
| Report date | 20260204 |
| Product type | Devices |
| Product quantity | 98 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.