Recall Z-1181-2024 ยท IYE Accelerator, Linear, Medical
PTW-FREIBURG
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.
| Date | Feb 22, 2024 (initiated Feb 8, 2024) |
| Status | Open, Classified |
| 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. |
| Root cause | Software design |
| Action | PTW Dosimetry issued Urgent Medical Device Correction letter via email on 2/8/24. Letter states reason for recall, health risk and action to take: PTW recommends not using the Suppress gamma calculation function for ROIs where a high proportion of voxels are to be suppressed in the gamma calculation. Since the malfunction is limited to the GPR calculation of ROIs and does not affect the GPR calculation of the VERIQA Total volume, it is recommended to rely on the comparison based on VERIQA Total. PTW will correct the malfunction in the next software version. The corrected version will be made |
| Quantity | 1 US; 65 worldwide |
| Distribution | GA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K213370 | VERIQA Ptw-Freiburg Physikalisch-Technische-Werkstaetten, Mar 30, 2022 |