AXIOM Sensis, Computer, Diagnostic, Programmable. Intended to be used as a diagnostic and administrative tool supporting hemodynamic cardiac catheterizations and/or intracardiac electrophysiology studies.
Reported: May 31, 2017 Initiated: April 12, 2017 #Z-2156-2017
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.
Details
- Recalling Firm
- Siemens Medical Solutions USA, Inc
- Units Affected
- 4,095
- Distribution
- Nationwide Distribution
- Location
- Malvern, PA
Frequently Asked Questions
What product was recalled? ▼
AXIOM Sensis, Computer, Diagnostic, Programmable. Intended to be used as a diagnostic and administrative tool supporting hemodynamic cardiac catheterizations and/or intracardiac electrophysiology studies.. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 4,095.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 31, 2017. Severity: Moderate. Recall number: Z-2156-2017.
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