# FDA recall Z-1175-2021

> **Canon Medical System, USA, INC.** · Class II · device recall initiated 2021-02-05.

## Product

System INFX-8000C

## Reason for recall

The x-ray irradiation field may shift with respect to image receiving surface displayed on the screen at some C-arm angles.

## Distribution

Nationwide

## Key facts

- **Recall number:** Z-1175-2021
- **Recalling firm:** Canon Medical System, USA, INC.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-02-05
- **Report date:** 2021-03-17

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1175-2021

## Citation

> AI Analytics. FDA recall Z-1175-2021. Retrieved 2026-06-10 from https://api.ai-analytics.org/recall/Z-1175-2021. Source: US FDA. Licensed CC0.

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