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Recall Observatory FDA recall evidence

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.

Z-1582-2025

February 25, 2025

Class II

Product summary

Firm
Philips North America Llc
Event
Event 96593
Status
Ongoing
Classification
Class II
Quantity
N/A
Official record key
device-enforcement:Z-1582-2025

Official wording

Reason: 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.

Code information: 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

Distribution pattern: US

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.