# FDA recall Z-1582-2025

> **Philips North America Llc** · Class II · device recall initiated 2025-02-25.

## Product

Veradius Unity. Product Code 718132. The devices are used for radiological guidance and visualization during diagnostic, interventional and  surgical procedures on all patients, except neonates (birth to one month), within the limits of the devices.

## Reason for recall

A wireless foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation.

## Distribution

US

## Key facts

- **Recall number:** Z-1582-2025
- **Recalling firm:** Philips North America Llc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-02-25
- **Report date:** 2025-04-30

- **Voluntary/Mandated:** FDA Mandated
- **Location:** Cambridge, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1582-2025

## Citation

> AI Analytics. FDA recall Z-1582-2025. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-1582-2025. Source: US FDA. Licensed CC0.

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