medical Class II Updated 2025-04-30

Philips North America Llc recalls Zenition 50. Product Code 718096. The devices are used for

Recalled Product

Zenition 50. Product Code 718096. 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.

Hazard / Issue

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.

Issued by

FDA

Distribution: US
Lot/Code Info: Product UDI: (01)00884838091535(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
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