FDA-Device2022-11-02Class II
ARTIS pheno, Interventional fluoroscopic x-ray system, Model No. 10849000
Siemens Medical Solutions USA, Inc
Hazard
Siemens has become aware of three potential software issues with ARTIS pheno systems with software version VE10B. This may lead to a hazardous situation for patients if treatment cannot be continued on the system and treatment needs to be continued on an alternate system.
Sold states
Domestic distribution nationwide. Foreign distribution worldwide.
Affected count
140 US
Manufactured in
40 Liberty Blvd, N/A, Malvern, PA, United States
Products
ARTIS pheno, Interventional fluoroscopic x-ray system, Model No. 10849000
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0119-2023Don't want to check this manually?
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