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Lower risk Medical device recall · FDA · Published November 16, 2022

Siemens Programmable Diagnostic Computer Software Update Recalled for Potential Procedure

Siemens recalls programmable diagnostic computers with software version VD12A due to potential procedure delays from software errors. Owners should check model numbers and contact Siemens for updates.

🇺🇸 FDA recall #Z-0775-2023Medical deviceSiemens ›
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Recalling firmSiemens Medical Solutions USA, Inc40 Liberty Blvd · Malvern, PA 19355-1418
✎ GovInfoNow plain-language explainer

Siemens is recalling programmable diagnostic computers with software version VD12A because software errors could cause delays or interruptions in medical procedures. This affects devices used in imaging and diagnostic settings. Read more at govinfonow.com/recall/59367-siemens-programmable-diagnostic-computer-software-update-recalled-for-potential-procedure.

Source Summary by GovInfoNow · govinfonow.com/recall/59367-siemens-programmable-diagnostic-computer-software-update-recalled-for-potential-procedure · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0775-2023

Cite this page

“Siemens Programmable Diagnostic Computer Software Update Recalled for Potential Procedure.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/59367-siemens-programmable-diagnostic-computer-software-update-recalled-for-potential-procedure. Based on FDA recall #Z-0775-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0775-2023%22&limit=1).

The FDA announced on November 16, 2022, that Siemens Medical Solutions USA, Inc. is recalling Programmable Diagnostic Computers due to software errors that may delay or interrupt medical procedures. The agency issued recall number Z-0775-2023 for the voluntary Class II recall.

How to tell if you have it

  • Brand: Siemens
  • Product: Programmable Diagnostic Computer
  • Models: Sensis, Sensis Vibe Hemo, Sensis Vibe Combo
  • Model Numbers: 10764561, 11007641, 11007642
  • UDI-DI Numbers: 04056869010137, 04056869010199, 04056869010205
  • Software Version: VD12A

The hazard

The recall addresses four potential software issues: a "PASSWORD STORE CORRUPTED" error during boot, subsystem crashes during examination, Dialog Monitor Computer application crashes while loading a study, and software crashes due to system internal timeout. These errors may lead to delays or interruptions in starting or continuing an examination or study.

Context

GovInfoNow's records show Siemens Medical Solutions USA, Inc. has 182 other recalls on record since June 6, 2017. Recent similar product recalls include the Philips Achieva 3.0T MRI recall for software issues terminating scans (August 21, 2026), the Philips PIC iX Essentials Software freeze recall for patient data issues (July 31, 2026), and the GE Medical Systems Portrait Compute V1.2 Software recall for patient monitoring risk (July 20, 2026).

How to tell if you have this one

Check for model numbers on the device: Sensis Vibe Hemo, Sensis Vibe Combo, or Sensis Vibe Combo with software version VD12A. The recall applies to all units with this specific software version.

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

What to do — step by step

  1. Check Software Version

    Verify the software version on your device; affected units have version VD12A.

  2. Contact Siemens

    Reach out to Siemens for software updates to resolve the issues.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

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. Worldwide foreign distribution to Albania Algeria Angola Argentina Armenia Australia Austria Azerbaijan Bahrain Bangladesh Belgium Bolivia Bosnia and Herzegovina Botswana Bulgaria Cambodia Canada Chile…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 56 days after the firm started it.

1. Firm started the recall: Nov 16, 202212. FDA classified it Class II: Dec 31, 202223. Published in FDA’s Enforcement Report: Jan 11, 2023320222023
  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-0775-2023 (November 16, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0775-2023 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