Recall Z-1581-2025 — Zenition 70. Product Code 718133. 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.
U.S. FDA — Device Enforcement · United States · 2025-02-25 · Class II
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Reported risk: 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.
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