FDA Device recall Z-1666-2022
INFX-8000V. For radiographic and fluoroscopic studies and intervention
- FDA Device
- Class II
- ongoing
- Published 2022-09-07
On 2022-09-07 the FDA classified a Class II recall of INFX-8000V. For radiographic and fluoroscopic studies and intervention by Canon Medical System Usa, citing the fluoroscopic dose rate might exceed the conforming value during biplane fluoroscopy.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1666-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-01-31 |
| Published | 2022-09-07 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Canon Medical System Usa |
| Distribution | US |
Product
INFX-8000V. For radiographic and fluoroscopic studies and intervention.
Reason
The fluoroscopic dose rate might exceed the conforming value during biplane fluoroscopy.
Identifiers
| code_info | Model: Alphenix i with software version 8.0, 9.0 or 9.2 and the TFP 1200C FPD. |
|---|
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-1666-2022%22
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