FDA-Device2018-11-21Class II
ARTIS zee biplane systems with Material 10094141- a Angiographic x-ray system Product Usage: Artis zee is a dedicated angiography system 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 includes cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body ra
Siemens Medical Solutions USA, Inc
Hazard
Vibrations of the C-arm of the plane B may result in reduced image quality caused by the screw connection to the C-arm in the ceiling support
Sold states
US Nationwide Distribution
Affected count
14 units
Manufactured in
40 Liberty Blvd, Malvern, PA, United States
Products
ARTIS zee biplane systems with Material 10094141- a Angiographic x-ray system Product Usage: Artis zee is a dedicated angiography system 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 includes cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis zee 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-0457-2019Don't want to check this manually?
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