FDA Device recall Z-0108-2027
Alphenix INFX-8000C/B5
- FDA Device
- Class II
- ongoing
- Published 2026-10-14
On 2026-10-14 the FDA classified a Class II recall of Alphenix INFX-8000C/B5 by Canon Medical System Usa, citing loosening of the bolts securing the longitudinal movement mechanism may cause the tabletop to shift, resulting in [positional/imaging/patient] misalignment and a longitudinal moti….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0108-2027 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-08-26 |
| Published | 2026-10-14 |
| Last updated | 2026-10-21 05:30 UTC |
| Company | Canon Medical System Usa |
| Distribution | US |
Product
Alphenix INFX-8000C/B5
Reason
Loosening of the bolts securing the longitudinal movement mechanism may cause the tabletop to shift, resulting in [positional/imaging/patient] misalignment and a longitudinal motion error
Identifiers
| code_info | Serial no. B5F2532011/UDI: 4987670100192 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-10-21 05:30 UTC. Current status: ongoing.
Other recalls by Canon Medical System Usa
- Alphenix Models INFX-8000C INFX-8000F INFX-8000V This device is a digital radiography/fluoroscopy system used in a diagnostic and intervent…
FDA Device · Class II · 2026-09-02 · Canon Medical System Usa - Alphenix INFX-8000V, interventional fluoroscopic x-ray system
FDA Device · Class II · 2026-02-04 · Canon Medical System Usa - Alphenix INFX-8000H, interventional fluoroscopic x-ray system
FDA Device · Class II · 2026-02-04 · Canon Medical System Usa - Alphenix INFX-8000F, interventional fluoroscopic x-ray system
FDA Device · Class II · 2026-02-04 · Canon Medical System Usa - Alphenix INFX-8000C, interventional fluoroscopic x-ray system
FDA Device · Class II · 2026-02-04 · Canon Medical System Usa
All Canon Medical System Usa recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0108-2027%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.