FDADecember 18, 2020device
ARTIS Icono biplane Model:11327600 ARTIS Icono floor system Model: 11327700 with software version VE20B - Product Usage: Intended for single and biplane diagnostic imaging and interventional procedures.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Misleading error messages and a gap in the Operator Manual which affects ARTIS Icono biplane or ARTIS Icono floor systems with software version VE20B. Potential issues include System error management, Erroneous error messages, Zoom/Pan Function, Grid Indication, and Coolant Level. May cause procedures to be terminated and performed on an alternative x-ray system
What to do
FDA enforcement status: Terminated
Brands named
siemens medical solutionssiemenssiemens medical
Recall history
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