FDA-Device2016-11-23Class II
AXIOM Artis, Angiographic x-ray system Product Usage: The Artis systems are 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 / zeego and Q/ Q.zen include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body
Siemens Medical Solutions USA, Inc
Hazard
The possibility exists that the semi-automatic focus switch may not work as intended when pressing the footswitch multiple times.
Sold states
US Nationwide Distribution.
Affected count
4,657 systems Worldwide
Manufactured in
40 Liberty Blvd, N/A, Malvern, PA, United States
Products
AXIOM Artis, Angiographic x-ray system Product Usage: The Artis systems are 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 / zeego and Q/ Q.zen include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis zee / zeego and Q/ Q.zen 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-0603-2017Don't want to check this manually?
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