PTW-FREIBURG Recall 93988
Description: 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.
PTW-FREIBURG Recall 93988 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1181-2024 |
| Event ID | 93988 |
| Event Description | 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. |
| Product Type | Devices |
| Distribution | GA |
| Quantity | 1 US; 65 worldwide |
| Recall Reason | 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. |
| Device Classification | 20240228 |
| Device Code Info | UDI-DI: EPTWS070031 Software VERIQA (S070031), version 2.0 and 2.1 |
| Center Classification Date | 20240222 |
| Recall Initiation Date | 20240208 |
| Recalling Firm | PTW-FREIBURG |
| Initial Notification | |
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