—#208937

Product

Sensis Vibe systems with software version VD15B in combination with AXIOM Sensis Post Processing Workstation-Intended to be used as a diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interventional Radiology as well as surgical studies. Equipped by modules, enabling various configurations. Model: 6648161

FDA product code: DQK — Computer, Diagnostic, Programmable
Device class: Class 2
Medical specialty: Cardiovascular
Affected lot / code info: UDI-DI: N/A Serial Numbers: 18904 18906

Why it was recalled

If the Sensis documentation functionality is used during adding of once-per-study reporting events (e.g., Type 1 events, as further defined in the administrator manual), the possibility exists that the application could crash.

Root cause (FDA determination)

Software design

Action the firm took

Siemens issued Urgent Medical Deice Correction letter (AX038/23/S-C) on 7/3/24 to Director of Diagnostic Imaging and/or Radiology Laboratory. Letter states reason for recall, health risk and action to take: If the Sensis documentation functionality is used and the described scenario occurs, users should continue the exam by opening a new study for the same patient without adding any Type 1 reporting events. You can compensate this by adding free text comments (procedure notes) only and manually inserting the desired information in those comments. Please ensure that patient treatment can be continued in other ways if there is any possible danger for the safety of the patient. How will the corrective action be implemented and what is the efficiency of the corrective actions? Siemens will correct the error with a software update via Update Instruction AX010/23/S. The corrective action mitigates the probability of occurrence of the issue. Based on our investigation you can continue to use your system/device. 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. Please review, understand, and confirm acknowledgement of the information and instructions outlined in this Customer Safety Advisory Notice. Please respond within 14 days of receiving this notification. If you have received this notification by email via Adobe GigaSign, kindly sign with your digital signature to acknowledge that you have read and understand the content provided. If you have received this customer notification by delivery by the US Postal Service or by FedEx, please send an email to recallsandrefusals.team@siemens-healthineers.com acknowledging that you have read and understand the content provided

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 40 Liberty Blvd, Malvern, Pennsylvania 19355-1418

Distribution

Distribution pattern: US Nationwide distribution in the states of CA, CT, FL, IA, KS, MA, MI, NJ, TX, VA.

Timeline

Recall initiated: 2024-07-03
Posted by FDA: 2024-07-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #208937. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.