FDA-Device2015-08-26Class II

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.

Siemens Medical Solutions USA, Inc
Hazard

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.

Sold states
Nationwide Distribution
Affected count
586
Manufactured in
51 Valley Stream Pkwy, Malvern, PA, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2404-2015

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