Siemens Medical Solutions USA, Inc 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

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

System may sporadically freeze (lock-up) during operation or while being in an idle state, no longer possible to interact with the system

Recommended Action

Per FDA guidance

Siemens issued Urgent Medical Device Correction via Customer Safety Advisory Notice AX010/21/S dated 1/27/21distributed to all affected customers. Additionally, a solution to eliminate the root cause of this problem is being distributed via Update Instruction AX009/21/S to all affected customers. Letter states reason for recall, health risk and action to take: The freeze is a total lock-up of the system and requires a power cycle of the PC to recover. Please make sure that an alternative system can be used to continue treatment in such cases.Our service organization will contact you shortly to arrange a date to perform this corrective action. Please feel free to contact our service organization for an earlier appointment at 1-800-888-7436. Following the correction, the cause is eliminated, and any recurrence of this potential fault is prevented. review, understand, and confirm acknowledgement of the information and instructions outlined in this Urgent Safety Advisory Notice. By signing this document, you are acknowledging that you have read and understand the content therein.