FDA Device recall Z-2392-2023
INFX-8000C XGCP-930AA TABLE SIDE CONSOLE, INFX-8000C XGCP-930BA TABLE SIDE CONSOLE
- FDA Device
- Class II
- ongoing
- Published 2023-08-16
On 2023-08-16 the FDA classified a Class II recall of INFX-8000C XGCP-930AA TABLE SIDE CONSOLE, INFX-8000C XGCP-930BA TABLE SIDE CONSOLE by Canon Medical System Usa, citing the C-arm, used to set the position and angle of the x-ray exposure field, may not function due to the tableside console PWB, which needs replacement. There may be a delay in the….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2392-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-06-22 |
| Published | 2023-08-16 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Canon Medical System Usa |
| Distribution | US |
Product
INFX-8000C XGCP-930AA TABLE SIDE CONSOLE, INFX-8000C XGCP-930BA TABLE SIDE CONSOLE
Reason
The C-arm, used to set the position and angle of the x-ray exposure field, may not function due to the tableside console PWB, which needs replacement. There may be a delay in the procedure, but procedures can continue using the operators console, the switches on the back of the column, switches on the side of the flat panel detector, and the emergency stop will continue to function normally.
Identifiers
| code_info | UDI-DI: 04987670100192. INFX-8000C, Serial Numbers: BHA1992001, BHB2132003, SWC2242002, AFB1832003, SUC2262008, SUC2292010, BFB1972004, SUB2172002, SWC2262003 |
|---|
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-2392-2023%22
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