Derived label

Device software or design

1. Sensis, material # 10764561; UDI: 04056869010137 2. Sensis Vibe Hemo, material # 11007641; UDI: 04056869010199 3. Sensis Vibe Combo, material # 11007642; UDI: 04056869010205 The Sensis recording system is a diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac, interventional Radiology, and surgical studies.

reason.device_software_design

v1.0.0

Assignment summary

Mode key: device_software_design
Evidence excerpt: Software error
Rule explanation: Device recall wording explicitly identifies a software, firmware, programming, cybersecurity, or design defect and its failure or consequence.
Firm: Siemens Medical Solutions USA, Inc