Software: If the user excludes voxels from the Gamma calculation that are below a dose threshold (Suppress gamma calculation), the Gamma Passing Rate (GPR) calculated for individual ROIs is not correct. The GPR calculated by VERIQA overestimates the correct GPR. The evaluation can therefore show false positive results.
Take action
Contact the company
📍Recalling firmPTW-FREIBURGLorracher Str. 7 · Freiburg Im Breisgau, Germany
“PTW-FREIBURG VERIQA Software Version 2.0/2.1: False Positive Results Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/56173-ptw-freiburg-veriqa-software-version-2-0-2-1-false. Based on FDA recall #Z-1181-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1181-2024%22&limit=1).
PTW-FREIBURG voluntarily recalled Software VERIQA (S070031), versions 2.0 and 2.1, because it may overestimate Gamma Passing Rates, according to the FDA. The Food and Drug Administration announced the recall on Feb. 8, 2024.
How to tell if you have it
Brand: PTW-FREIBURG
Product: Software VERIQA (S070031), version 2.0 and 2.1-
UDI-DI: EPTWS070031
The hazard
The software may calculate incorrect Gamma Passing Rates for individual ROIs if users exclude voxels below a dose threshold. This error can lead to false positive results in the evaluation of medical image data sets and treatment plans.
Context
GovInfoNow's records show PTW-FREIBURG has two other recalls on record since June 7, 2023. On Aug. 4, 2026, the firm recalled VERIQA RT MonteCarlo 3D v3 due to potential incorrect dose delivery when bolus inclusion is not clearly displayed. Other recent recalls of similar products include RayStation/RayPlan Software 11A Recalls (Nov. 28, 2025) and RayStation Software Version 15.2.0/15.1.3 (Nov. 28, 2025).
How to tell if you have this one
Check for VERIQA software version 2.0 or 2.1 with UDI-DI code EPTWS070031. The software is used in radiation oncology for treatment planning and evaluation.
Brand
PTW-FREIBURG
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Verify your VERIQA software version by checking the product documentation or software settings.
Where it went and when
Where it was distributed
Distributed in Georgia.
Listed by the agency
Not listed
FDA distribution: “GA” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Georgia.
Recall timeline
FDA published this recall 20 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
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-1181-2024 (February 8, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1181-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.