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Lower risk Medical device recall · FDA · Published July 3, 2024

Siemens Sensis Vibe Systems with VD15B Software May Crash During Reporting Events

Siemens recalls Sensis Vibe systems with VD15B software that may crash when adding certain reporting events. Affected units have specific serial numbers and model numbers. No action is required but users should update software.

🇺🇸 FDA recall #Z-2438-2024Medical deviceSiemens Medical Solutions ›
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Recalling firmSiemens Medical Solutions USA, Inc40 Liberty Blvd · Malvern, PA 19355-1418
✎ GovInfoNow plain-language explainer

What happened, in plain English

Siemens is recalling Sensis Vibe systems with software version VD15B that may crash when adding specific reporting events. This could disrupt medical procedures but does not pose a direct safety risk to users. Read more at govinfonow.com/recall/54695-siemens-sensis-vibe-systems-with-vd15b-software-may-crash-during.

Source Summary by GovInfoNow · govinfonow.com/recall/54695-siemens-sensis-vibe-systems-with-vd15b-software-may-crash-during · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2438-2024

Cite this page

“Siemens Sensis Vibe Systems with VD15B Software May Crash During Reporting Events.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54695-siemens-sensis-vibe-systems-with-vd15b-software-may-crash-during. Based on FDA recall #Z-2438-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2438-2024%22&limit=1).

Why it’s dangerous

The software may crash when adding certain types of reporting events, such as Type 1 events, during diagnostic procedures. This could disrupt medical workflows but does not cause physical harm to users.

Who’s affected

Healthcare providers using Sensis Vibe systems with software version VD:15B for cardiac or interventional radiology procedures are most at risk. Patients are not directly affected by this issue.

How to tell if you have this one

Check for serial numbers starting with 15000-15003 and model number 10910620. The software version is VD15B when combined with Sensis High End Server.

  • Brand
    Siemens Medical Solutions
  • Category
    Medical device
FDA recall event · 4 products

All 4 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • Distribution
    US Nationwide distribution in the states of CA, CT, FL, IA, KS, MA, MI, NJ, TX, VA.
Recall numberProduct, codes & lotsQuantity
Z-2438-2024Sensis Vibe systems with software version VD15B in combination with Sensis High End Server -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: 10910620; UDI-DI: N/A Serial Numbers: 15000 15001 150033 systems
Z-2439-2024Sensis Vibe systems with software version VD15B in combination with VM VIRTUAL SERVER Model: 10765502-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.; UDI-DI: N/A Serial Numbers: Serial 18023 18022 18020 18021 18019 18025 180177 systems
Z-2440-2024Sensis Vibe systems with software version VD15B in combination with AXIOM Sensis Post Processing Workstation-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: 6648161; UDI-DI: N/A Serial Numbers: 18904 189062 systems
Z-2441-2024Sensis 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; UDI-DI: 4056869010199 Serial Numbers: 18009 18010 18011 18014 18015 18016 19001 103584 103596 104064 106244 106245 ***Update 7/24/24*** S/N Added: 10218312 units
Based on the official FDA remedy

What to do — step by step

  1. Check Software Version

    Verify the software version on your Sensis Vibe system. If it is VD15B, it is affected.

  2. Update Software

    Contact Siemens to update to a newer software version that resolves the crash issue.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 10 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: nationwideILWisconsin: nationwideWIMichigan: named in the noticeMINew York: nationwideNYRhode Island: nationwideRIMassachusetts: named in the noticeMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: named in the noticeIAIndiana: nationwideINOhio: nationwideOHPennsylvania: nationwidePANew Jersey: named in the noticeNJConnecticut: named in the noticeCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: named in the noticeVAMaryland: nationwideMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: named in the noticeKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: nationwideNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: nationwideALGeorgia: nationwideGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “US Nationwide distribution in the states of CA, CT, FL, IA, KS, MA, MI, NJ, TX, VA.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: California, Connecticut, Florida, Iowa, Kansas, Massachusetts, Michigan, New Jersey, Texas, Virginia.

Recall timeline

FDA published this recall 28 days after the firm started it.

1. Firm started the recall: Jul 3, 202412. FDA classified it Class II: Jul 25, 202423. Published in FDA’s Enforcement Report: Jul 31, 202432024
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-2438-2024 (July 3, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2438-2024 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.