Recall Z-2156-2017 — AXIOM Sensis, Computer, Diagnostic, Programmable. Intended to be used as a diagnostic and administrative tool supporting hemodynamic cardiac catheterizations and/or intracardiac electrophysiology studies.
U.S. FDA — Device Enforcement · United States · 2017-04-12 · Class II
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Reported risk: 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.
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