FDA-Device2021-05-05Class II
Interventional Fluoroscopic X-Ray System ARTIS icono biplane- 11327600 ARTIS icono floor- 11327700 ARTIS pheno- 10849000 ARTIS is 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.
Hazard
Siemens has become aware of a potential issue with software version VE20C. Planned procedures may have to be terminated and performed on an alternative x-ray system.
Sold states
Worldwide distribution: US (nationwide) including states of: CA, CO, DE, FL, IL, IN, KY, MD, MI, NC, NE, NJ, NY, OH, TN, TX, UT, WI, and OUS (countries) of: AT, BE, ES, IT, FI, CH, FR, GB, SE, DE, DK, IE and NL.
Affected count
133 systems
Manufactured in
40 Liberty Blvd, N/A, Malvern, PA, United States
Products
Interventional Fluoroscopic X-Ray System ARTIS icono biplane- 11327600 ARTIS icono floor- 11327700 ARTIS pheno- 10849000 ARTIS is 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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1497-2021More Siemens Medical Solutions USA, Inc recalls
- FDA-Device2026-07-08ARTIS icono ceiling. Model Number: 11328100.
- FDA-Device2026-07-08ARTIS icono floor. Model Number: 11327700.
- FDA-Device2026-07-08ARTIS icono biplane. Model Number: 11327600.
- FDA-Device2026-07-08ARTIS icono ceiling. Model Number: 11328100.
- FDA-Device2026-04-22Siemens ARTIS Pheno VE30A and VE40A imaging system recalled for potential unintended radiation exposure
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