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Lower risk Medical device recall · FDA · Published October 5, 2021

Siemens Sensis/Sensis Vibe Systems with VD1X Software May Cause Interface Freeze

Siemens recalls Sensis and Sensis Vibe systems with VD1X software due to rare interface freezes after 7 days without reboot. Affected units have specific serial numbers.

🇺🇸 FDA recall #Z-0226-2022Medical deviceSiemens ›
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Recalling firmSiemens Medical Solutions USA, Inc40 Liberty Blvd · Malvern, PA 19355-1418
✎ GovInfoNow plain-language explainer

Siemens is recalling Sensis and Sensis Vibe medical devices with VD1X software because users not following the 7-day reboot schedule may cause the system to partially freeze, preventing vital sign updates. This is rare but could disrupt critical medical monitoring. Read more at govinfonow.com/recall/61717-siemens-sensis-sensis-vibe-systems-with-vd1x-software-may-cause.

Source Summary by GovInfoNow · govinfonow.com/recall/61717-siemens-sensis-sensis-vibe-systems-with-vd1x-software-may-cause · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0226-2022

Cite this page

“Siemens Sensis/Sensis Vibe Systems with VD1X Software May Cause Interface Freeze.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61717-siemens-sensis-sensis-vibe-systems-with-vd1x-software-may-cause. Based on FDA recall #Z-0226-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0226-2022%22&limit=1).

The FDA announced on Oct. 5, 2021, that Siemens Medical Solutions USA, Inc. is recalling Sensis and Sensis Vibe systems with software VD1X due to a potential user interface freeze. The agency stated the hazard could result in vital signs no longer updating.

How to tell if you have it

  • Sensis Model 10764561
  • Sensis Vibe Hemo Model 11007641
  • Sensis Vibe Combo Model 11007642

The hazard

The system operator manual states that the system should be rebooted once every seven days. In some cases, users are not following these instructions and the system is running for more than seven days. Under rare circumstances, this may result in a partial freeze of the user interface which would no longer update the vital signs.

Context

GovInfoNow's records show Siemens Medical Solutions USA, Inc. has 182 other recalls on record since June 6, 2017. Other recent recalls of similar products include Philips PIC iX Essentials Software Freezes (July 31, 2026), Philips Patient Information Center iX Software Freezes (July 31, 2026), and GE Medical Systems Portrait Core Services SW Reload V1.1 Software Issue (July 20, 2026).

How to tell if you have this one

Check if your device has the Sensis Model 10764561 or Sensis Vibe Hemo Model 11007641. The full list of affected serial numbers is provided in the recall notice.

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

What to do — step by step

  1. Check System Reboot Schedule

    Review your device's manual to confirm it reboots every 7 days as required by the manufacturer.

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

Distributed nationwide.

Recall timeline

FDA published this recall 50 days after the firm started it.

1. Firm started the recall: Oct 5, 202112. FDA classified it Class II: Nov 16, 202123. Published in FDA’s Enforcement Report: Nov 24, 202132021
  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-0226-2022 (October 5, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0226-2022 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