FDA Device recall Z-1174-2021
System INFX-8000V
- FDA Device
- Class II
- ongoing
- Published 2021-03-17
On 2021-03-17 the FDA classified a Class II recall of System INFX-8000V by Canon Medical System Usa, citing the x-ray irradiation field may shift with respect to image receiving surface displayed on the screen at some C-arm angles.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1174-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-02-05 |
| Published | 2021-03-17 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Canon Medical System Usa |
| Distribution | US |
Product
System INFX-8000V
Reason
The x-ray irradiation field may shift with respect to image receiving surface displayed on the screen at some C-arm angles.
Identifiers
| code_info | Model: CAS-880A, CAS-830B |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Other recalls by Canon Medical System Usa
- Alphenix INFX-8000C/B5
FDA Device · Class II · 2026-10-14 · 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
All Canon Medical System Usa recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1174-2021%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.