FDA-Device2021-03-10Class II
Sensis / Sensis Vibe systems with software version VD12 and equipped with HP Flex Pro-C PC. Diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies Model Numbers: Sensis Vibe Hemo 11007641 Sensis Vibe Combo 11007642 Sensis 10764561 Postprocessing Workstation 6648161 SIS Server 6648153
Siemens Medical Solutions USA, Inc
Hazard
System may sporadically freeze (lock-up) during operation or while being in an idle state, no longer possible to interact with the system
Sold states
US Nationwide distribution in the states of AK, AR, CA, GU, IA, IL, MI, MO, NC, NE, OR, PA, PA, PR, SD, TN, TX, WA.
Affected count
37 US
Manufactured in
40 Liberty Blvd, Malvern, PA, United States
Products
Sensis / Sensis Vibe systems with software version VD12 and equipped with HP Flex Pro-C PC. Diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies Model Numbers: Sensis Vibe Hemo 11007641 Sensis Vibe Combo 11007642 Sensis 10764561 Postprocessing Workstation 6648161 SIS Server 6648153
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1173-2021Don't want to check this manually?
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