# FDA recall Z-2392-2023

> **Canon Medical System, USA, INC.** · Class II · device recall initiated 2023-06-22.

## 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.

## Distribution

US Nationwide Distribution: NY, CO, IL, CA, MD, MN, WA

## Key facts

- **Recall number:** Z-2392-2023
- **Recalling firm:** Canon Medical System, USA, INC.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-06-22
- **Report date:** 2023-08-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Tustin, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2392-2023

## Citation

> AI Analytics. FDA recall Z-2392-2023. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-2392-2023. Source: US FDA. Licensed CC0.

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