Use caution Medical device recall · FDA · Published November 23, 2021

Siemens Sensis Medical Devices Recall: Software Error May Cause CO Measurement Failure

Siemens recalls Sensis and Sensis Vibe Hemo systems with software version VD12A due to potential CO measurement failure in cardiac procedures. Affected units have specific serial numbers and materials.

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

🇺🇸 FDA recall #Z-0499-2022Medical device Siemens ›

Use caution until it’s fixed

Software error which affects Sensis Vibe Hemo, Sensis and Sensis Vibe Combo systems with software version VD12A, which could cause possible hazard to patients, operators, or other persons and equipment. Under certain sporadic circumstances, the CO (Cardiac Output) measurement using the Thermodilution method will temporarily no longer be possible.

Take action

Contact the company

Recalling firmSiemens Medical Solutions USA, Inc40 Liberty Blvd · Malvern, PA 19355-1418

✎ GovInfoNow plain-language explainer

Siemens is recalling certain Sensis and Sensis Vibe Hemo medical devices that have a software error in version VD12A. This error could cause the system to temporarily fail at measuring cardiac output using the thermodilution method during procedures, potentially affecting patient or operator safety. Read more at govinfonow.com/recall/61504-siemens-sensis-medical-devices-recall-software-error-may-cause-co.

Source Summary by GovInfoNow · govinfonow.com/recall/61504-siemens-sensis-medical-devices-recall-software-error-may-cause-co · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0499-2022

Cite this page

“Siemens Sensis Medical Devices Recall: Software Error May Cause CO Measurement Failure.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61504-siemens-sensis-medical-devices-recall-software-error-may-cause-co. Based on FDA recall #Z-0499-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0499-2022%22&limit=1).

The FDA announced on November 23, 2021, that Siemens Medical Solutions USA, Inc. is recalling Sensis, Sensis Vibe Hemo, and Sensis Vibe Combo systems due to a software error that may prevent cardiac output measurements. The agency issued recall number Z-0499-2021 for the voluntary Class II recall affecting 1,047 units distributed nationwide.

How to tell if you have it

Brand: Siemens
Product: Sensis, material # 10764561; UDI: 04056869010137
Product: Sensis Vibe Hemo, material # 11007641; UDI: 04056869010199
Product: Sensis Vibe Combo, material # 11007642; UDI: 04056869010205
Software version: VD12A
Units affected: 1047

The hazard

According to the FDA, a software error in systems with software version VD12A could cause a hazard to patients, operators, or other persons and equipment. Under certain sporadic circumstances, the cardiac output measurement using the Thermodilution method will temporarily no longer be possible.

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 Siemens ARTIS icono Ceiling Monitor Recall (June 8, 2026), Siemens ARTIS Icono Biplane Recall (May 20, 2026), and Siemens ARTIS Pheno VE30A/VE40A Recall (March 12, 2026). Other recent recalls of similar products include Spacelabs Healthcare Multi-parameter Command Module Model 91496 Recall (February 27, 2026), Philips Cardiac Workstation 7000 Recall (July 1, 2026), and Siemens Healthcare Syva EMIT 2000 Quinidine Assay Recall (July 13, 2026).

How to tell if you have this one

Check for the product name (Sensis, Sensis Vibe Hemo, or Sensis Vibe Combo) with specific serial numbers listed in the recall notice. The affected units have material numbers 10764561, 11007641, or 11007642 and unique UDI codes.

Brand
Siemens
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Software Version
Verify the software version on your device; affected units have version VD12A.
Review Serial Numbers
Check if your device's serial numbers match those listed in the recall notice (e.g., Sensis Vibe Hemo serial numbers 103137, 103144, etc.).

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 28 states.

FDA distribution: “US Nationwide distribution in the states of AK, AL, AR, AZ, CA, FL, GU, HI, IA, IL, IN, KS, KY, MA, MI, MO, MS, NC, NE, NJ, NY, OH, OK,PA, PR, SD, TN, TX, WA, WV.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Florida, Hawaii, Illinois, Indiana, Iowa, Kansas, Kentucky, Massachusetts, Michigan, Mississippi, Missouri, Nebraska, New Jersey, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Dakota, Tennessee, Texas, Washington, West Virginia.

Recall timeline

FDA published this recall 2 months after the firm started it.

Nov 23, 2021Firm started the recall
Jan 14, 2022FDA classified it Class II
Jan 26, 2022Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/61504-siemens-sensis-medical-devices-recall-software-error-may-cause-co">Siemens Sensis Medical Devices Recall: Software Error May Cause CO Measurement Failure (GovInfoNow)</a>

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-0499-2022 (November 23, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0499-2022 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.