FDA-Device2025-04-30Class II
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.
Philips North America Llc
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.
Sold states
US
Affected count
N/A
Manufactured in
222 Jacobs St, N/A, Cambridge, MA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1580-2025Don't want to check this manually?
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