FDA-Device2017-07-26Class II
Artis zee,x-ray system, angiographic Artis zee is a family of 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 with the Artis zee include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis zee sys
Siemens Medical Solutions USA, Inc
Hazard
Failures can result due to a component defect on Artis zee systems with an A100 Plus generator of a certain delivery lot and 2-focus Megalix Cat Plus tube unit.
Sold states
Worldwide Distribution - US to AR, KS, MI, IA, IL, WI, MN, WV, OH, and NY
Affected count
97 distributed worldwide, 12 distributed in United States
Manufactured in
40 Liberty Blvd, N/A, Malvern, PA, United States
Products
Artis zee,x-ray system, angiographic Artis zee is a family of 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 with the Artis zee include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis zee systems can also support the acquisition of position triggered imaging for spatial data synthesis
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2686-2017Don't want to check this manually?
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