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Lower risk Medical device recall · FDA · Published January 27, 2021

Siemens Sensis Vibe Systems with VD12 Software May Freeze During Use

Siemens recalls Sensis Vibe systems with software version VD12 and HP Flex Pro-C PC that may sporadically freeze, preventing interaction with the system during operation or idle states.

🇺🇸 FDA recall #Z-1173-2021Medical deviceSiemens ›
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Recalling firmSiemens Medical Solutions USA, Inc40 Liberty Blvd · Malvern, PA 19355
✎ GovInfoNow plain-language explainer

What happened, in plain English

Siemens is recalling Sensis Vibe systems with specific software versions and HP Flex Pro-C PCs that may freeze unexpectedly, making the system unresponsive. This could disrupt medical procedures and require immediate attention to prevent operational failures. Read more at govinfonow.com/recall/63345-siemens-sensis-vibe-systems-with-vd12-software-may-freeze-during.

Source Summary by GovInfoNow · govinfonow.com/recall/63345-siemens-sensis-vibe-systems-with-vd12-software-may-freeze-during · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1173-2021

Cite this page

“Siemens Sensis Vibe Systems with VD12 Software May Freeze During Use.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63345-siemens-sensis-vibe-systems-with-vd12-software-may-freeze-during. Based on FDA recall #Z-1173-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1173-2021%22&limit=1).

Why it’s dangerous

The system may freeze unexpectedly during operation or when idle, preventing users from interacting with it. This could lead to interruptions in medical procedures, but the recall does not indicate a risk of injury or serious harm to patients or staff.

Who’s affected

Healthcare providers using Sensis Vibe systems for hemodynamic catheterizations or electrophysiology studies are most at risk. Patients receiving care during system freezes may experience delays or interruptions in treatment.

How to tell if you have this one

Check for Sensis Vibe Hemo (model 11007641), Sensis Vibe Combo (11007642), or Sensis (10764561) systems with software version VD12 and HP Flex Pro-C PC. Serial numbers listed in the recall include 10704, 18900, and others.

  • Brand
    Siemens
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Software Version

    Verify if your system has software version VD12 and is equipped with HP Flex Pro-C PC.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 15 states.

Alaska: named in the noticeAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: named in the noticeWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: named in the noticeILWisconsin: nationwideWIMichigan: named in the noticeMINew York: nationwideNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: named in the noticeORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: named in the noticeSDIowa: named in the noticeIAIndiana: nationwideINOhio: nationwideOHPennsylvania: named in the noticePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: nationwideCONebraska: named in the noticeNEMissouri: named in the noticeMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: nationwideMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: named in the noticeARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: nationwideALGeorgia: nationwideGAHawaii: nationwideHITexas: named in the noticeTXFlorida: nationwideFLPuerto Rico: named in the noticePR

FDA distribution: “US Nationwide distribution in the states of AK, AR, CA, GU, IA, IL, MI, MO, NC, NE, OR, PA, PA, PR, SD, TN, TX, WA.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alaska, Arkansas, California, Illinois, Iowa, Michigan, Missouri, Nebraska, North Carolina, Oregon, Pennsylvania, Puerto Rico, South Dakota, Tennessee, Texas, Washington.

Recall timeline

FDA terminated this recall 9 months after the firm started it.

1. Firm started the recall: Jan 27, 202112. FDA classified it Class II: Mar 4, 202123. Published in FDA’s Enforcement Report: Mar 10, 202134. FDA terminated the recall: Oct 25, 202142021
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

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-1173-2021 (January 27, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1173-2021 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA