FDA Device recall Z-1175-2021
System INFX-8000C
- FDA Device
- Class II
- ongoing
- Published 2021-03-17
On 2021-03-17 the FDA classified a Class II recall of System INFX-8000C 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-1175-2021 |
| 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-8000C
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.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1175-2021%22
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