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Open, Classified

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 Recall Z-1426-2022 · Posted None

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusOpen, Classified
Product CodeDQK
Date Initiated2022-06-15
Product Quantity13 units

Reason for Recall

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.

Firm Action

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

Root Cause

Device Design

Distribution Pattern

US Nationwide Distribution AZ FL KY MI OH PR TX

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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