Siemens Medical Solutions USA, Inc Sensis with software version VD12A. A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interventional Radiology Model:10764561 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Sensis with software version VD12A. A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interventional Radiology Model:10764561
Brand
Siemens Medical Solutions USA, Inc
Lot Codes / Batch Numbers
UDI-DI: 04056869010137 Serial Numbers: 61331, 60015
Products Sold
UDI-DI: 04056869010137 Serial Numbers: 61331, 60015
Siemens Medical Solutions USA, Inc is recalling Sensis with software version VD12A. A diagnostic and administrative tool supporting hemodynamic ca due to Sensis/Sensis Vibe SoftwareVD12A, the ComboBox may encounter a disconnect of its communication during the first patient examination of the day or afte. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026