FDA-Device2022-04-27Class II
Artis icono biplane- in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use single and biplane diagnostic imaging and interventional procedures. Model: 11327600
Siemens Medical Solutions USA, Inc
Hazard
Five potential software issues affecting Artis pheno and Artis icono systems in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). The potential software errors are related to the block movements function and manual rotation of the flat detector. Depending on the status of the intervention, the limited functionality may not be sufficient to continue with treatment as planned. This may result in a situation where clinical treatment may be delayed until an additional restart is performed
Sold states
US Nationwide distribution.
Affected count
94 U.S.
Manufactured in
40 Liberty Blvd, Malvern, PA, United States
Products
Artis icono biplane- in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use single and biplane diagnostic imaging and interventional procedures. Model: 11327600
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0985-2022Don't want to check this manually?
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