FDA-Device2017-05-31Class II
AXIOM Sensis, Computer, Diagnostic, Programmable. Intended to be used as a diagnostic and administrative tool supporting hemodynamic cardiac catheterizations and/or intracardiac electrophysiology studies.
Hazard
An extremely dusty computer can cause problems at system start, or rarely, cause system fail. Perform a system check prior to performing exams. If the Sensis system fails, its functions can not be used. Clinical treatment may need to be terminated, restarted, or transferred to a functioning system.
Sold states
Nationwide Distribution
Affected count
4,095
Manufactured in
40 Liberty Blvd, Malvern, PA, United States
Products
AXIOM Sensis, Computer, Diagnostic, Programmable. Intended to be used as a diagnostic and administrative tool supporting hemodynamic cardiac catheterizations and/or intracardiac electrophysiology studies.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2156-2017More Siemens Medical Solutions USA, Inc recalls
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