Philips North America Llc recalls Zenition 50. Product Code 718096. The devices are used for radiological guidance and visualization during diagnostic, i…
- Recall date
- February 25, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1580-2025
- FDA classification
- Class II
- Brand / firm
- Philips North America Llc
- Sold / distributed
- US
Why it was recalled
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.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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.
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