Recall Z-2156-2017— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-2156-2017
Creator: U.S. Food and Drug Administration
Published: 2017-04-12

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2017-04-12, terminated 2018-05-15. It names one FDA 510(k) clearance: K020440. 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.. 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: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2017-04-12
Terminated: 2018-05-15
Firm location: Malvern, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K020440 — NEWCORSiemens Medical Systems, Inc.·cleared 2002-12-03

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

AXIOM Sensis, Computer, Diagnostic, Programmable. Intended to be used as a diagnostic and administrative tool supporting hemodynamic cardiac catheterizations and/or intracardiac electrophysiology studies.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.