# FDA recall Z-1243-2026

> **Focalyx Technologies, LLC.** · Class II · device recall initiated 2025-12-23.

## Product

Focalyx Fusion

## Reason for recall

Software device that is an accessory for image-guided interventional and diagnostic procedures involving prostate has accessories that may not function properly with Windows 10, which may cause patient harm during biopsy or cause treatment/therapy delays, so firm is recommending stop use until device is verified/validated with Windows 11.

## Distribution

Worldwide - US Nationwide distribution in the states of NY, MA, FL and the countries of ES, VE, DO.

## Key facts

- **Recall number:** Z-1243-2026
- **Recalling firm:** Focalyx Technologies, LLC.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-12-23
- **Report date:** 2026-02-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Hialeah, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1243-2026

## Citation

> AI Analytics. FDA recall Z-1243-2026. Retrieved 2026-08-21 from https://api.ai-analytics.org/recall/Z-1243-2026. Source: US FDA. Licensed CC0.

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