INFX-8000C XGCP-930AA TABLE SIDE CONSOLE — Class II medical device recall Z-2392-2023
Ongoing recall by Canon Medical System, USA, INC., reported 2023-08-16, distributed nationwide. The C-arm, used to set the position and angle of the x-ray exposure field, may not function due to the tablesi
| Recall number | Z-2392-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Canon Medical System, USA, INC., Tustin, CA, United States |
| Recall initiated | 2023-06-22 |
| Classified | 2023-08-10 |
| Reported by FDA | 2023-08-16 |
| Distributed | Nationwide (US) |
| Quantity | 12 |
| UPC / GTIN / UDI-DI | 04987670100192 |
| Serial numbers | AFB1832003, BFB1972004, BHA1992001, BHB2132003, SUB2172002, SUC2262008, SUC2292010, SWC2242002, SWC2262003 |
Product
INFX-8000C XGCP-930AA TABLE SIDE CONSOLE, INFX-8000C XGCP-930BA TABLE SIDE CONSOLE
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2392-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.