Sensis Vibe Combo with software version VD12A. A… recallZ-1426-2022 · Siemens Medical Solutions USA, Inc · initiated Jun 15, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Siemens Medical Solutions USA, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Device Design
What the company is doing
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
Recall details
- Recall number
- Z-1426-2022
- Status
- Open, Classified
- Initiated by the company
- Jun 15, 2022
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 13 units
- Product code
- DQK
- FDA submissions
- K150493
- Distribution
- US Nationwide Distribution AZ FL KY MI OH PR TX
Product description
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
Code information (models, lots, serial numbers)
UDI-DI: 04056869010205 Serial Numbers: 123021, 123055, 123056, 123058, 122042, 123004, 122006, 122026, 122029, 123047, 123053, 122011, 121014.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Sensis Vibe Combo 11007642Siemens Healthcare GmbH · COMPUTER, DIAGNOSTIC, PROGRAMMABLE4 recalls1 death6 reports
Other devices under the same FDA submission
1 device cleared under K150493 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Sensis 10764561Siemens Healthcare GmbH · COMPUTER, DIAGNOSTIC, PROGRAMMABLE5 recalls8 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 90504).
- Z-1425-2022 · Open, ClassifiedSensis with software version VD12A. A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interven…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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