FDA-Device2017-03-29Class II
ARTIS Q, Interventional Fluroscopic x-ray system
Siemens Medical Solutions USA, Inc
Hazard
In Artis systems with A100G generators, a component can be affected by aging which could result in the potential failure of a module in the high-voltage generator.
Sold states
Distributed throughout the United States.
Affected count
264 distributed worldwide (112 in the U.S.)
Manufactured in
40 Liberty Blvd, Malvern, PA, United States
Products
ARTIS Q, Interventional Fluroscopic x-ray system
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1534-2017Don't want to check this manually?
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