—#185684

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

FDA product code: DQK — Computer, Diagnostic, Programmable
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K150493
Affected lot / code info: Software version VD12 and equipped with HP Flex Pro-C PC Serial Numbers: 10704 18900 18901 103008 103014 103019 103022 103039 103040 103042 103047 103048 103053 103079 103080 103082 103086 103088 103089 103090 103115 103116 103117 103119 103123 103124 103130 103131 103137 103144 103145 103148 103152 103160 103170 103171 123004

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

Root cause (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 40 Liberty Blvd, Malvern, Pennsylvania 19355

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2021-01-27
Terminated: 2021-10-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #185684. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.