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Siemens Medical Solutions USA, Inc recalls ARTIS pheno- angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Mod
Recalled July 14, 2021 · FDA recall Z-2029-2021 · Siemens Medical Solutions USA
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 · FDA Class II
Units
116 units
Sold at
US Nationwide
Description
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
Product
ARTIS pheno- angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Model: 10849000
Manufacturer(s)
Siemens Medical Solutions USA, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →