AXIOM Sensis, Computer, Diagnostic, Programmable. Intended to be used as a diagnostic and administrative tool supporting hemodynamic cardiac catheterizations and/or intracardiac electrophysiology studies.
FDA Recall Z-2156-2017 · Posted None
Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeDQK
Date Initiated2017-04-12
Date Terminated2018-05-15
Product Quantity4,095
Reason for Recall
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.
Firm Action
Siemens mailed a Customer Safety Advisory Notice (CSAN) to affected customers on 04/12/2017 to inform them of the issue. The Notice explained the issue and when it can occur, the possible risks involved, and the actions consignees should take to address the issue. For questions regarding this recall call 610-219-4834.
Root Cause
Material/Component Contamination
Distribution Pattern
Nationwide Distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.