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Use caution Medical device recall · FDA · Published March 4, 2021

Siemens Sensis Vibe Hemo Systems with VD12A Software Risk: Data Exposure and Incorrect

Siemens recalls Sensis Vibe Hemo systems with VD12A software due to Windows service permissions configuration risks. This could lead to data exposure, manipulation, or denial of service attacks, potentially causing incorrect medical decisions. Affected units include specific server and workstation models with serial numbers from August 24, 2022.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1434-2021Medical deviceSiemens Medical Solutions ›
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Recalling firmSiemens Medical Solutions USA, Inc40 Liberty Blvd · Malvern, PA 19355
✎ GovInfoNow plain-language explainer

Siemens is recalling Sensis Vibe Hemo systems with VD12A software because of a security vulnerability in Windows service permissions. This could expose sensitive patient data, manipulate medical records, or cause system failures that might lead to incorrect treatment decisions. Read more at govinfonow.com/recall/63167-siemens-sensis-vibe-hemo-systems-with-vd12a-software-risk-data.

Source Summary by GovInfoNow · govinfonow.com/recall/63167-siemens-sensis-vibe-hemo-systems-with-vd12a-software-risk-data · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1434-2021

Cite this page

“Siemens Sensis Vibe Hemo Systems with VD12A Software Risk: Data Exposure and Incorrect.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63167-siemens-sensis-vibe-hemo-systems-with-vd12a-software-risk-data. Based on FDA recall #Z-1434-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1434-2021%22&limit=1).

The FDA announced on March 4, 2021, that Siemens Medical Solutions USA, Inc. is recalling Sensis and Sensis Vibe Hemo systems with VD12A software due to cybersecurity vulnerabilities. The agency stated the risk includes exposure of sensitive information or data manipulation that could lead to incorrect diagnostic decisions.

How to tell if you have it

  • Brand: Siemens Medical Solutions
  • Product: Sensis/ Sensis Vibe Hemo systems with VD12A software
  • Dedicated SIS Server- 6648153
  • Sensis Post-Processing Workstation- 6648161
  • Sensis- 10764561
  • VM Virtual Server- 10765502
  • Sensis High-End Servers- 10910620
  • Sensis Vibe Hemo- 11007641
  • Sensis Vibe Combo- 11007642
  • Serial Numbers: 10661, 11657, 14000, 14012, 14123, 14312, 14603, 14804, 14900, 14902, 15010, 15130, 15135, 15136, 15819, 15829, 15902, 15903, 15904, 15908, 15913, 15915, 15916, 15917, 15920, 15923, 15924, 15925, 15926, 15927, 15928, 18900, 18901, 100208, 100209, 100216, 100306, 100309, 102138, 102145, 102147, 102221, 102326, 103014, 103019, 103022, 103039, 103040, 103042, 103047, 103048, 103079, 103080, 103082, 103086, 103088, 103089, 103090, 103108, 103111, 103114, 103115, 103116, 103117, 103119, 103123, 103124, 103130, 103131, 103139, 103144, 103145, 103148, 103152, 103160, 103161, 103166, 103167, 103168, 103170, 103171, 103172, 103173, 103177, 103178, 103182, 103184, 103186, 103189, 103193, 103194, 103196, 103198, 103199, 103200, 103208, 103216, 123004, 123021
  • Units affected: 99

The hazard

According to the FDA, the configuration of certain Windows Service Permissions within the operating systems of the Sensis/ Sensis Vibe computer creates a risk for exposure of sensitive information, manipulation of data, or Denial of Service attacks. These vulnerabilities could result in incorrect diagnostic or therapeutic decisions.

Context

GovInfoNow's records show Siemens Medical Solutions USA, Inc has 182 other recalls on record since 2017-06-06. Other recent recalls of similar products include the Siemens ARTIS icono Ceiling Monitor Recall (2026-06-08), the Siemens ARTIS icono floor recall (2026-05-20), and the Siemens ARTIS Pheno VE30A/VE40A recall (2026-03-12). Other recent recalls of similar products include the GE Medical Systems Centricity Universal Viewer Software Cybersecurity Recall (2026-01-30), the GE Healthcare Patient Monitor Software Vulnerability (2026-07-10), and the GE HealthCare APEXPRO v5.0 Software Risk (2026-04-24).

How to tell if you have this one

Check if your Sensis Vibe Hemo system has the VD12A software version. Affected units include specific server models with serial numbers listed from August 24, 2022, such as 6648153, 6648161, and others.

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

What to do — step by step

  1. Check Software Version

    Verify if your system has the VD12A software version by checking the serial numbers listed in the recall notice.

  2. Contact Siemens

    Reach out to Siemens Medical Solutions for guidance on updating the software or other remedial actions.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 3.6 years after the firm started it.

1. Firm started the recall: Mar 4, 202112. FDA classified it Class II: Apr 19, 202123. Published in FDA’s Enforcement Report: Apr 28, 202134. FDA terminated the recall: Sep 30, 2024420212024
  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-1434-2021 (March 4, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1434-2021 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