FDA-Device2021-07-14Class II
ARTIS pheno- angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Model: 10849000
Siemens Medical Solutions USA, Inc
Hazard
Software error VE10B -In case of a fault within the drivetrain of an axis and while performing a stepped peripheral imaging (PERISTEPPING/PERIVISION), the C-arm may leave its intended travel path by up to 22 cm (9") result in canceling clinical treatment or to continue treatment on an alternative system
Sold states
US Nationwide
Affected count
116 units
Manufactured in
40 Liberty Blvd, Malvern, PA, United States
Products
ARTIS pheno- angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Model: 10849000
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2029-2021Don't want to check this manually?
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