Philips North America Llc recalls Veradius Unity. Product Code 718132. The devices are used for radiological guidance and visualization during diagnostic…

Recall date

February 25, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1582-2025

FDA classification

Class II

Brand / firm

Philips North America Llc

Sold / distributed

US

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.