FDAFDA · Food and drugs·Recall number Z-1582-2025
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.
Published April 30, 2025 · Recall initiated: February 25, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
FDA Mandated · Letter
Recall details
- Manufacturer
- Philips North America Llc
- Distributor
- US
- Lot
- Product UDI: (01)00884838058194(21) 459801442981, Wireless foot switch set 3P (WFSS 3P) 459801238231, Wireless foot switch 3P, 459801257861, WFS Base Station 459800627394, Wireless foot switch set 3P 459800415535, Wireless foot switch 3P, 459800415542, WFS Base Station
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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