FDA DevicesClass II
Alphenix INFX-8000C, interventional fluoroscopic x-ray system
Published: February 4, 2026Recall ID: Z-1176-2026Category: 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-8000C, 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: W1C0632284, W4A1282279, W4A12Z2324, A2A2222381, A2A2392756, A3517001, A2A2352683, A2A2072087, A2A2072077, C1C2422647, W2A09Y2061, W2A10X2168, W4A11Y2144, A2A2232406, A2A2032038, W1D07Z2458, W2A09X2053, B2B1812645, A1C19Z2182, W4B1332362, B2A1622324, W4C1352385, W4A1292284, A1C19X2152, A1C1942058, A1C1972104, B2A1592233, B2A1792598, W2A1012081, W2A1052121, W4C1342374, B2B1872766, A4562105, W2A0972027, A1C2052199, A2A21X2339, W2A1012082, W4C1342369, W1D07Z2449, A1C1942065, A2A2132228, A2A2172285, A2A2117001, W1D06Z2357, A2A2282477, A2A2232405, W1B08X2034, A2A2182313, W4A1232210, A2A2262452, B2A16X2449, B2B1862743, B2B1872751, W1D0697014, W1C05X2229, B2A1542162, A2A21Z2364, A2A2392751, B2A1722527, A2A22Z2566, B4582115, W4C1372400, A2A2362690, A2A2252436, A2A2292510, B2A1582209, B2A1472014, W1D0732376, A2A2252439, W1D0732374, A1C1972105, A1C1972112, B4602126, W1B08Z2063, A2A2152265, A2A2132230, A2A2282491, A2A2262445, A2A22Y2550, A2A22X2528, W4A1212180, W4A1212176, W4A1212... [TRUNCATED] |
| Postal code | 92780-7047 |
| Report date | 20260204 |
| Product type | Devices |
| Product quantity | 172 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.