FDA-Device2022-06-15Class II
Artis icono biplane -angiography systems developed for single and biplane diagnostic imaging and interventional procedures SMN: 11327600
Hazard
if the protective earth is interrupted and an additional fault leads to a fault current, the detection of the fault current may not be ensured may cause an electric shock if a person is in contact with metallic parts of the Carm
Sold states
US Nationwide distribution.
Affected count
51 units
Manufactured in
40 Liberty Blvd, Malvern, PA, United States
Products
Artis icono biplane -angiography systems developed for single and biplane diagnostic imaging and interventional procedures SMN: 11327600
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1245-2022More 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.
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