Software VERIQA — Class II medical device recall Z-1181-2024
Ongoing recall by PTW-FREIBURG, reported 2024-02-28, distributed in GA. Software: If the user excludes voxels from the Gamma calculation that are below a dose threshold (Suppress gam
| Recall number | Z-1181-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | PTW-FREIBURG, Freiburg Im Breisgau, N/A, Germany |
| Recall initiated | 2024-02-08 |
| Classified | 2024-02-22 |
| Reported by FDA | 2024-02-28 |
| Distributed | GA |
| Reason classes | software |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1181-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.