FDA Medical Device Recalls (openFDA)
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 number
- Z-1425-2022
- Recalling firm
- Siemens Medical Solutions USA, Inc
- 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
- Status
- Open, Classified
- Initiated
- 2022-06-15
- Posted
- not on file
- Terminated
- not on file
- Reason
- 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
- Device Design
- 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
- Quantity
- 2 units
- Distribution
- US Nationwide Distribution AZ FL KY MI OH PR TX
- Lot, serial or model codes
- UDI-DI: 04056869010137 Serial Numbers: 61331, 60015
- 510(k) numbers
- ["K150493"]
- PMA numbers
- not on file
- Product code
- DQK
- Firm FEI
- 2240869
- Firm city
- Malvern
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28