FDA DevicesClass II
Alphenix INFX-8000V, interventional fluoroscopic x-ray system
Published: February 4, 2026Recall ID: Z-1179-2026Category: 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-8000V, 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: B2A1522117, E0514103, B2A15X2238, B2A1792589, A2A2242418, A2A21X2345, B2A1692413, A2A2152263, A2A2262450, A2A22Z2576, W4A1252250, A2A20Z2167, W4A10X2001, A2A2412831, W1C0552181, W1D0842501, W4D13Z2452, W4A1322350, W4D1422467, B2A1472002, A1C1982123, W2A1062134, W1B08X2042, W2A1072139, W4A1242220, A2A2382741, B2A17Z2627, A2A2152264, W4C1362387, W4D1422465, D4W1262257, W1D0892543, W4D1462478, W4A1182118, W4A11X2133, W4A11Z2167, N/A Deinstalled, A1B18Z7003, W4A1252243, DFP800A-0001, A3552017, W2A1092165, W1D0882537, A2A2122203, W4A10Z2022, W4B1332361, A2A23Y2788, W4A12Z2328, B2A1662374, W4A12Z2329, B2A1622309, B2A14X2056, A2A2272459, A2A2172291, W4A1132061, W1D0832488, W1D0882536, W2A0962022, W2A0982038, W2A0972026, B2A1642351, A2A2152255, W1D0752392, A2A2182308, A2A2412836, A2A2112189, A2A21X2336, A1C19Y2164, A1C1942056, A2A2192328, A2A2332643, W4C1372398, A2A22Y2553, A2A2132226, W4A1262256, B2A1472013, W2A1022097, W2A1022094, W4A10Z2017, W1B08Y2055, B2A1492051, B2A14920... [TRUNCATED] |
| Postal code | 92780-7047 |
| Report date | 20260204 |
| Product type | Devices |
| Product quantity | 332 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.