# FDA recall Z-1176-2026

> **Canon Medical System, USA, INC.** · Class II · device recall initiated 2025-12-19.

## Product

Alphenix INFX-8000C, interventional fluoroscopic x-ray system

## Reason for recall

It has been discovered that there is a possibility that the fixing screws of the ceiling movement gear in the ceiling suspended arm that are part of the X-ray interventional   systems may become loose. As a result, ceiling lateral movement may no longer be possible, abnormal noise may be generated from the suspension system and a sensor error may be displayed

## Distribution

Worldwide distribution - US Nationwide and the country of Dominican Republic.

## Key facts

- **Recall number:** Z-1176-2026
- **Recalling firm:** Canon Medical System, USA, INC.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-12-19
- **Report date:** 2026-02-04

- **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-1176-2026

## Citation

> AI Analytics. FDA recall Z-1176-2026. Retrieved 2026-07-11 from https://api.ai-analytics.org/recall/Z-1176-2026. Source: US FDA. Licensed CC0.

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