Lower risk Medical device recall · FDA · Published March 7, 2022

Siemens syngo.via RT Image Suite software recall: Wrong laser coordinates in patient

Siemens recalls syngo.via RT Image Suite software version VB60 for SOMATOM go.Up scanners. Upgraded software may display incorrect laser coordinates during patient marking, risking misalignment. Affected units have specific model numbers and serials.

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

🇺🇸 FDA recall #Z-0995-2022Medical device Siemens ›

Lower-risk recall

Upgraded software version makes an automatic change in laser configuration settings for "markerless workflow" which may lead to the wrong laser offset coordinates being displayed in the Patient Marking step.

Take action

Contact the company

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

✎ GovInfoNow plain-language explainer

Siemens is recalling a software upgrade for certain medical imaging systems. The update could cause the system to show incorrect laser coordinates during patient marking, potentially leading to misalignment of treatment. This is a software issue that requires correction to ensure accurate patient positioning. Read more at govinfonow.com/recall/60979-siemens-syngo-via-rt-image-suite-software-recall-wrong-laser.

Source Summary by GovInfoNow · govinfonow.com/recall/60979-siemens-syngo-via-rt-image-suite-software-recall-wrong-laser · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0995-2022

Cite this page

“Siemens syngo.via RT Image Suite software recall: Wrong laser coordinates in patient.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60979-siemens-syngo-via-rt-image-suite-software-recall-wrong-laser. Based on FDA recall #Z-0995-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0995-2022%22&limit=1).

The FDA announced on March 7, 2022, that Siemens Medical Solutions USA, Inc. is recalling syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Up due to a software hazard. The recall involves one unit distributed in the United States and internationally.

How to tell if you have it

Brand: Siemens
Product: syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Up
Model Number: 11061620
Partial UDI: 04056869051314
Serial Number: 112261

The hazard

The upgraded software version makes an automatic change in laser configuration settings for "markerless workflow" which may lead to the wrong laser offset coordinates being displayed in the Patient Marking step.

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 Elekta Leksell GammaPlan 11.1 Software Recall (Dec. 12, 2025), Elekta Leksell Vantage Arc System Recall (March 19, 2026), and Hitachi Proton Beam Therapy System Recall (Feb. 6, 2026).

How to tell if you have this one

Check if your Siemens SOMATOM go.Up scanner has the syngo.via RT Image Suite software version VB60. The product includes a specific model number (11061620) and partial UDI (04056869051314) with serial number 112261.

Brand
Siemens
Category
Medical device

FDA recall event · 4 products

All 4 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Terminated
Distribution
Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, IL, IN, KY, MD, MO, ND, NH, NY, OH, OR, PA, SD, TX, VA and the countries of Argentina, Austria, Bahrain, Belgium, Brazil, Czechia, Denmark, France, Germany, Hungary, India, Italy, Japan, Netherlands, Norway, Poland, Romania, Slovakia, Spain, Switzerland, United Kingdom.

Recall number	Product, codes & lots	Quantity
Z-0994-2022	syngo.via RT Image Suite upgraded to VB60 running on syngo.via Model Number 10496180. Running on servers with syngo.via VB60 software after upgrade and CT scanners with syngo.CT VA40A after upgrade.; Serial Number 133527	1 (US)
Z-0995-2022	syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Up Model Number 11061620. Running on servers with syngo.via VB60 software after upgrade and CT scanners with syngo.CT VA40A after upgrade.; Partial UDI: 04056869051314, Serial Number 112261	1 (US)
Z-0996-2022	syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Sim Model Number 11061660. Running on servers with syngo.via VB60 software after upgrade and CT scanners with syngo.CT VA40A after upgrade.; Partial UDI: 04056869249230, Serial Numbers 128123, 128106, 128109, 128144, 128124, 128112, 128132, 128135, 128114, 128125, 128113, 128142, 128107, 128136, 128133	15 (US)
Z-0997-2022	syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Open Pro Model Number 11061670. Running on servers with syngo.via VB60 software after upgrade and CT scanners with syngo.CT VA40A after upgrade.; Partial UDI: 04056869249247, Serial Numbers 130088, 130081, 130075, 130090, 130087, 130074, 130069, 130091, 130092, 130086, 130079, 130089, 130077, 130071	14 (US)

Based on the official FDA remedy

What to do — step by step

Check Software Version
Verify your syngo.via RT Image Suite software version is VB60 by checking the system settings.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 20 states.

FDA distribution: “Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, IL, IN, KY, MD, MO, ND, NH, NY, OH, OR, PA, SD, TX, VA and the countries of Argentina, Austria, Bahrain, Belgium, Brazil, Czechia, Denmark,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Illinois, Indiana, Kentucky, Maryland, Missouri, New Hampshire, New York, North Dakota, Ohio, Oregon, Pennsylvania, South Dakota, Texas, Virginia.

Recall timeline

FDA terminated this recall 21 months after the firm started it.

Mar 7, 2022Firm started the recall
Apr 22, 2022FDA classified it Class II
May 4, 2022Published in FDA’s Enforcement Report
Dec 19, 2023FDA terminated the recall

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

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Is this recall dangerous?

The recall is for a software update that may cause incorrect laser coordinates during patient marking, but it does not pose a risk of serious injury or death. The hazard is low risk as it affects accuracy rather than safety.

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Link to this recall

<a href="https://govinfonow.com/recall/60979-siemens-syngo-via-rt-image-suite-software-recall-wrong-laser">Siemens syngo.via RT Image Suite software recall: Wrong laser coordinates in patient (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-0995-2022 (March 7, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0995-2022 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.