# FDA recall Z-1181-2024

> **PTW-FREIBURG** · Class II · device recall initiated 2024-02-08.

## Product

Software VERIQA (S070031), version 2.0 and 2.1- Software package for display, evaluation and digital processing of medical image data sets and treatment plans in radiation oncology.

## Reason for recall

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.

## Distribution

GA

## Key facts

- **Recall number:** Z-1181-2024
- **Recalling firm:** PTW-FREIBURG
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-02-08
- **Report date:** 2024-02-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Freiburg Im Breisgau, N/A, Germany

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1181-2024

## Citation

> AI Analytics. FDA recall Z-1181-2024. Retrieved 2026-09-15 from https://api.ai-analytics.org/recall/Z-1181-2024. Source: US FDA. Licensed CC0.

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