Company: Siemens Medical Solutions USA, Inc
Date of Enforcement Report: 3/10/2021
Class II
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.
Recall Number: Z-1173-2021
REASON
System may sporadically freeze (lock-up) during operation or while being in an idle state, no longer possible to interact with the system.
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc. on 1/27/2021. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
37 US
DISTRIBUTION
U.S. Nationwide