Z-2441-2024Class II

Sensis Vibe systems with software version VD15B-Intended to be used as a diagnostic and administrative tool...

Name: Z-2441-2024 Sensis Vibe systems with software version VD15B-Intended to be used as a diagnostic and administrative tool...
Creator: Siemens Medical Solutions USA, Inc
Published: 2024-07-03
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2024-07-03 / Open, Classified / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of Sensis Vibe systems with software version VD15B-Intended to be used as a diagnostic and administrative tool supporting hemodynamic catheterizations and/or... on 2024-07-03. FDA classified it as Class II and gives the reason as "If the Sensis documentation functionality is used during adding of once-per-study reporting events (e.g., Type 1 events, as further defined in the administrator manual), the possibility exists that the application could...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2441-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-07-03
Posted: 2024-07-25
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Sensis Vibe systems with software version VD15B-Intended to be used as a diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interventional Radiology as well as surgical studies. Equipped by modules, enabling various configurations. Model: 11007641
Product code: DQK Computer, Diagnostic, Programmable
Reason for recall: If the Sensis documentation functionality is used during adding of once-per-study reporting events (e.g., Type 1 events, as further defined in the administrator manual), the possibility exists that the application could crash.
Root cause tag: software
FDA root cause: Software design
Action: Siemens issued Urgent Medical Deice Correction letter (AX038/23/S-C) on 7/3/24 to Director of Diagnostic Imaging and/or Radiology Laboratory. Letter states reason for recall, health risk and action to take: If the Sensis documentation functionality is used and the described scenario occurs, users should continue the exam by opening a new study for the same patient without adding any Type 1 reporting events. You can compensate this by adding free text comments (procedure notes) only and manually inserting the desired information in those comments. Please ensure that patient treatment can be continued in other ways if there is any possible danger for the safety of the patient. How will the corrective action be implemented and what is the efficiency of the corrective actions? Siemens will correct the error with a software update via Update Instruction AX010/23/S. The corrective action mitigates the probability of occurrence of the issue. Based on our investigation you can continue to use your system/device. 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 Customer Safety Advisory Notice. Please respond within 14 days of receiving this notification. If you have received this notification by email via Adobe GigaSign, kindly sign with your digital signature to acknowledge that you have read and understand the content provided. If you have received this customer notification by delivery by the US Postal Service or by FedEx, please send an email to [email protected] acknowledging that you have read and understand the content provided
Quantity in commerce: 12 units
Distribution: US Nationwide distribution in the states of CA, CT, FL, IA, KS, MA, MI, NJ, TX, VA.
Product codes and lots: UDI-DI: 4056869010199 Serial Numbers: 18009 18010 18011 18014 18015 18016 19001 103584 103596 104064 106244 106245 ***Update 7/24/24*** S/N Added: 102183

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2441-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2438-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-31	2024-07-25
Z-2439-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-31	2024-07-25
Z-2440-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-31	2024-07-25
Z-2441-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-31	2024-07-25

Product code DQK

K223812Class IISensis Vibe (VD15)Siemens Medical Solutions USA, Inc. / cleared 2023-09-15

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)