FDA-Device2021-12-01Class II
Artis zee biplane with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10094141
Siemens Medical Solutions USA, Inc
Hazard
If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result in a short delay in procedure
Sold states
US Nationwide Distribution
Affected count
2 units
Manufactured in
40 Liberty Blvd, Malvern, PA, United States
Products
Artis zee biplane with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10094141
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0299-2022Don't want to check this manually?
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