Recall Z-2404-2015 — Artis zee/ zeego systems; dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
U.S. FDA — Device Enforcement · United States · 2015-06-30 · Class II
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Reported risk: in case a system error occurs and the system enters the "Bypass Fluoro" mode while the X-ray locking function is active, the only way to exit the X-ray locking function, would be to either resolve the root cause of the system being in "Bypass Fluoro" or to restart the system.
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