Reported Mar 10, 2021 · Terminated
Sensis / Sensis Vibe systems with software version VD12 and equipped with HP Flex Pro-C PC. Diagnostic and…
Siemens Medical Solutions USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Medical Solutions USA, Inc · 40 Liberty Blvd · Malvern, PA · 19355
Is this the product you have?
- 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 NumbersSensis Vibe Hemo 11007641 Sensis Vibe Combo 11007642 Sensis 10764561 Postprocessing Workstation 6648161 SIS Server 6648153
- Lot codes and dates
- Software version VD12 and equipped
- with HP Flex Pro-C PC Serial Numbers
107041890018901103008103014103019103022103039103040103042103047103048103053103079103080103082103086103088103089103090103115103116103117103119103123103124103130103131103137103144103145103148103152103160103170103171123004
- Amount recalled
- 37 US
Where it was sold
Why it was recalled
System may sporadically freeze (lock-up) during operation or while being in an idle state, no longer possible to interact with the system
This product could cause temporary or reversible health problems — stop using it.
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