Lower riskMedical device recall · FDA · Published August 4, 2026
VERIQA RT MonteCarlo 3D v3 Software Error May Cause Incorrect Dose Delivery
VERIQA RT MonteCarlo 3D v3 software version 3.1.18 may not clearly display bolus in treatment plans, risking incorrect radiation dose delivery to tissues. Affected units include model S070031.520.
When a bolus is included in a treatment plan and sent for secondary dose calculation, the software accounts for it but does not display this clearly, which may lead users to incorrectly omit the bolus during treatment and deliver the prescribed dose to the wrong tissue depth.
“VERIQA RT MonteCarlo 3D v3 Software Error May Cause Incorrect Dose Delivery.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/1134635-veriqa-rt-montecarlo-3d-v3-software-error-may-cause-incorrect. Based on FDA recall #Z-3174-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3174-2026%22&limit=1).
The FDA announced on 2026-08-04 that PTW-FREIBURG is recalling the VERIQA RT MonteCarlo 3D v3 software due to a hazard that may lead users to deliver prescribed doses to the wrong tissue depth. The agency issued recall number Z-3174-2026 for the voluntary Class II action.
How to tell if you have it
Brand: VERIQA
Product Name: RT MonteCarlo 3D v3
Model/Catalog Number: S070031.520
Software Version: 3.1.18
UDI-DI: +EPTWS070031Q5200
The hazard
When a bolus is included in a treatment plan and sent for secondary dose calculation, the software accounts for it but does not display this clearly. This may lead users to incorrectly omit the bolus during treatment and deliver the prescribed dose to the wrong tissue depth.
Context
GovInfoNow's records show PTW-FREIBURG has issued two other recalls since 2023-06-07, including a 2024-02-08 recall for VERIQA Software Version 2.0/2.1 regarding false positive results risk and a 2023-06-07 recall for BeamAdjust Software 2.3.3 involving incorrect calibration results. Other recent recalls of similar products include RayStation Software Version 12A Recalls (2025-11-28), RayStation 2024B Software Recall (2025-11-28), and RayStation 10B Software May Cause Radiation Dose Errors - Recall (2025-11-28).
How to tell if you have this one
Check for software version 3.1.18 on the VERIQA RT MonteCarlo 3D v3 system with model number S070031.520. The UDI-DI code +EPTWS070031Q5200 may also be present.
Brand
VERIQA
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Verify the software version is 3.1.18 on the VERIQA RT MonteCarlo 3D v3 system with model S070031.520.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 2 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide - US Nationwide distribution in the states of GA, NY and the countries of Austria, Belgium, Switzerland, Czechia, Germany, Spain, France, Netherlands, Norway, Poland, Portugal, Romania, T¿rkiye, Chile, United Arab Emirates, Saudi…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Georgia, New York.
Recall timeline
FDA published this recall 50 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4Added to GovInfoNow
Dates from the agency record only; steps without a date are left out.
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-3174-2026 (August 4, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3174-2026 to see it in context.
Plain-language summary written by qwen3:4b on October 4, 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.