Recall Z-2156-2017 ยท DQK Computer, Diagnostic, Programmable
Siemens Medical Solutions USA, Inc
AXIOM Sensis, Computer, Diagnostic, Programmable. Intended to be used as a diagnostic and administrative tool supporting hemodynamic cardiac catheterizations and/or intracardiac electrophysiology studies.
| Date | Apr 12, 2017 |
| Status | Terminated |
| 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. |
| Root cause | Material/Component Contamination |
| 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. |
| Quantity | 4,095 |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K020440 | NEWCOR Siemens Medical Systems, Inc., Dec 3, 2002 |