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Use caution Medical device recall · FDA · Published April 13, 2022

Siemens Sensis Diagnostic Computer Recall: Risk of treatment interruption

Siemens recalls Sensis programmable diagnostic computers with specific model numbers due to potential software issues that may cause treatment interruptions for patients.

🇺🇸 FDA recall #Z-1243-2022Medical deviceSiemens Medical Solutions ›
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Contact the company

Recalling firmSiemens Medical Solutions USA, Inc40 Liberty Blvd · Malvern, PA 19355-1418
✎ GovInfoNow plain-language explainer

Siemens is recalling certain Sensis programmable diagnostic computers because of software issues that could prevent treatment from continuing if a patient needs to switch systems. This affects specific model numbers listed in the recall notice. Read more at govinfonow.com/recall/60815-siemens-sensis-diagnostic-computer-recall-risk-of-treatment-interruption.

Source Summary by GovInfoNow · govinfonow.com/recall/60815-siemens-sensis-diagnostic-computer-recall-risk-of-treatment-interruption · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1243-2022

Cite this page

“Siemens Sensis Diagnostic Computer Recall: Risk of treatment interruption.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60815-siemens-sensis-diagnostic-computer-recall-risk-of-treatment-interruption. Based on FDA recall #Z-1243-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1243-2022%22&limit=1).

The FDA announced on April 13, 2022, that Siemens Medical Solutions USA, Inc. is recalling Sensis Programmable Diagnostic Computers due to potential software issues that may prevent treatment continuation. Owners should contact the company for a remedy.

How to tell if you have it

  • Brand: Siemens Medical Solutions
  • Product: Sensis, Programmable Diagnostic Computer
  • Model Nos.: 6623974, 6634633, 6634658, 6648153, 6648161, 10140973, 10764561, 10765502, 10910620
  • Distribution: Domestic distribution nationwide

The hazard

Siemens has become aware of three potential software issues with AXIOM Sensis or Sensis/ Sensis Lite systems. This may lead to a hazardous situation for patients if treatment cannot be continued on the system and treatment needs to be continued on an alternate system.

Context

GovInfoNow's records show Siemens Medical Solutions USA, Inc. has had 182 other recalls since June 6, 2017. Recent similar product recalls include a Fresenius Medical Care 5008X CAREsystem recall for software anomalies on Oct. 25, 2025, and Philips PIC iX Essentials and Patient Information Center iX software freeze recalls on July 31, 2026.

How to tell if you have this one

Check the model numbers listed in the recall notice: 6623974, 6634633, 6634658, 6648153, 6648161, 10140973, 10764561, 10765502, and 10910620. The recall includes specific material serial numbers as well.

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

What to do — step by step

  1. Check Model Numbers

    Verify your Sensis diagnostic computer's model number against the list provided in the recall notice.

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: “Domestic 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 2 months after the firm started it.

1. Firm started the recall: Apr 13, 202212. FDA classified it Class II: Jun 6, 202223. Published in FDA’s Enforcement Report: Jun 15, 202232022
  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.

✎ GovInfoNow

Questions people ask

Do I need to stop using my Sensis computer immediately?

No, the recall does not require immediate discontinuation. However, you should check your model number to see if it is affected.

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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-1243-2022 (April 13, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1243-2022 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