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Siemens Medical Solutions USA, Inc recalls Sensis / Sensis Vibe systems with software version VD12 and equipped with HP Flex Pro-C PC. Diagnostic and administrati
Recalled March 10, 2021 · FDA recall Z-1173-2021 · Siemens Medical Solutions USA
Hazard
System may sporadically freeze (lock-up) during operation or while being in an idle state, no longer possible to interact with the system · FDA Class II
Units
37 US
Sold at
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.
Description
System may sporadically freeze (lock-up) during operation or while being in an idle state, no longer possible to interact with the system
Product
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
Manufacturer(s)
Siemens Medical Solutions USA, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →