FDA recall Z-1582-2025

Philips North America Llc · Class II · device

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

Status
Ongoing
Initiation date
2025-02-25
Report date
2025-04-30
Voluntary/Mandated
FDA Mandated
Location
Cambridge, MA, United States

Primary source

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