—#194604

Product

Sensis Vibe Combo with software version VD12A. A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interventional Radiology Model: 11007642

FDA product code: DQK — Computer, Diagnostic, Programmable
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K150493
Affected lot / code info: UDI-DI: 04056869010205 Serial Numbers: 123021, 123055, 123056, 123058, 122042, 123004, 122006, 122026, 122029, 123047, 123053, 122011, 121014.

Why it was recalled

Sensis/Sensis Vibe SoftwareVD12A, the ComboBox may encounter a disconnect of its communication during the first patient examination of the day or after a longer period of inactivity to the Sensis Vibe system resulting in no vital signs being available.

Root cause (FDA determination)

Device Design

Action the firm took

Siemens issued a Customer Safety Advisory Notice (AX016/22/S) dated 6/15/22 distributed to customers. Letter states reason for recall, health risk and action to take. The BIOS configuration of the ComboBox in the affected systems will be updated to correct the issue. This corrective action will be distributed via Update Instruction AX015/22/S. 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 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 19355-1418

Distribution

Distribution pattern: US Nationwide Distribution AZ FL KY MI OH PR TX

Timeline

Recall initiated: 2022-06-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #194604. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.