Z-1426-2022Class II

Sensis Vibe Combo with software version VD12A. A diagnostic and administrative tool supporting hemodynamic...

Name: Z-1426-2022 Sensis Vibe Combo with software version VD12A. A diagnostic and administrative tool supporting hemodynamic...
Creator: Siemens Medical Solutions USA, Inc
Published: 2022-06-15
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2022-06-15 / Open, Classified / root cause: design

FDA source

Siemens Medical Solutions USA, Inc began a recall of Sensis Vibe Combo with software version VD12A. A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies... on 2022-06-15. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1426-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-06-15
Posted: 2022-07-20
Recalling firm: Siemens Medical Solutions USA, Inc.
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
Product code: DQK Computer, Diagnostic, Programmable
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.
Root cause tag: design
FDA 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 in commerce: 13 units
Distribution: US Nationwide Distribution AZ FL KY MI OH PR TX
Product codes and lots: UDI-DI: 04056869010205 Serial Numbers: 123021, 123055, 123056, 123058, 122042, 123004, 122006, 122026, 122029, 123047, 123053, 122011, 121014.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1426-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1425-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-07-27	2022-07-20
Z-1426-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-07-27	2022-07-20

Product code DQK

K150493Class IISensisSiemens Medi Cal Solutions, Inc. / cleared 2015-06-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)