Company: Siemens Medical Solutions USA, Inc
Date of Enforcement Report 5/31/2017
Class lI:
PRODUCT
AXIOM Sensis, Computer, Diagnostic, Programmable. Intended to be used as a diagnostic and administrative tool supporting hemodynamic cardiac catheterizations and/or intracardiac electrophysiology studies..
Recall Number Z-2156-2017
REASON
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
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Malvern, PA on 4/12/2017. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
4,095
DISTRIBUTION
Nationwide Distribution
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