FDA-Device2015-01-21Class II
Artis zee/ zeego systems, model numbers: 10094135, 10094137, 10094139, 10094141, 10280959: dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.
Siemens Medical Solutions USA, Inc
Hazard
The Small Focus of a 3 focal spot x-ray tube may fail and further release of radiation will not be possible. The Large Focus and Micro Focus focal spots will still be operational without any restriction. Manual switchover is needed, resulting in a short interruption of the procedure.
Sold states
USA Distribution to the states of MO, MI, NY, OK, CA, LA, CT, IN, VA, MD, WA, HI, ME, TX, NY, OH, PA and CO.
Affected count
44
Manufactured in
40 Liberty Blvd, Mail Code: 65-1A, Malvern, PA, United States
Products
Artis zee/ zeego systems, model numbers: 10094135, 10094137, 10094139, 10094141, 10280959: dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0854-2015Don't want to check this manually?
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