PTW-FREIBURG recalls software versions 2.0 and 2.1 of VERIQA for potential false positive results in radiation oncology treatment evaluations.
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.
PTW-FREIBURG is recalling software versions 2.0 and 2.1 of VERIQA due to a risk of false positive results in radiation treatment evaluations. This could lead to incorrect conclusions about treatment effectiveness.
The software may incorrectly calculate the Gamma Passing Rate (GPR) when certain voxels are excluded from dose calculations. This leads to false positive results, potentially causing incorrect treatment decisions.
Radiation oncology professionals who use VERIQA software versions 2.0 and 2.1 for treatment planning and evaluation. Those most at risk are clinicians relying on the software for accurate dose calculations.
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.
Verify your VERIQA software version by checking the product documentation or software settings.
The software may incorrectly calculate the Gamma Passing Rate (GPR) when certain voxels are excluded from dose calculations, leading to false positive results in treatment evaluations.
Check for VERIQA software version 2.0 or 2.1 with UDI-DI code EPTWS070031, which is used in radiation oncology for treatment planning and evaluation.
The recall does not specify a remedy, so no action is required unless you want to update to a newer version.
We’ve drafted a message you can send PTW-FREIBURG to request your refund or repair — edit it as you like.
Subject: Recall Z-1181-2024 — PTW-FREIBURG PTW-FREIBURG Hello, I own a PTW-FREIBURG that is covered by recall Z-1181-2024 from PTW-FREIBURG. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.