Recall Z-1281-2023 ยท MUJ System, Planning, Radiation Therapy Treatment
RAYSEARCH LABORATORIES AB
Raystation treatment planning system for radiation therapy, Model Numbers 9.0.0, 9.0.1, 9.1.0, 9.2.0, 10.0.0, 10.0.1, 10.0.2, 10.1.0, 10.1.1, 11.0.0, 11.0.1, 11.0.3, 11.0.4, 12.0.0, 12.1.0, 12.1.1, 12.0.3, 12.1.2, 12.0.4, 12.1.3, 13.0.0, 13.1.0. Software Version Numbers 9A, 9B, 10A, 10B, 11A, 11B and 12A including service packs
| Date | Mar 22, 2023 (initiated Feb 17, 2023) |
| Status | Open, Classified |
| Reason | It is possible to set a non-zero collimator angle in the Virtual Simulation module. The angle will be correct in the user interface but if the plan is DICOM exported by using the VSIM Export button, the angle will not be correct in the exported RT plan. In the exported RT plan, the DICOM attribute Beam Limiting Device Angle (300A,0120) is set to zero, regardless of the selected collimator angle. |
| Root cause | Under Investigation by firm |
| Action | A Field Safety Notice, Medical Device Correction letter dated 2/16/23 was sent to customers. Actions to be taken by the user " Be aware that an RT plan exported by using the VSIM Export button will always have the DICOM attribute Beam Limiting Device Angle (300A,0120) set to zero. " Be aware that an RT plan exported by using the VSIM Export button will always have the DICOM attribute Number of Wedges (300A,00D0) set to zero and no wedge information will be exported. " Be aware that an RT plan exported by using the VSIM Export button will never include the DICOM attribute Applicator Sequ |
| Quantity | 10770 systems |
| Distribution | US Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K190387 | RayStation RaySearch Laboratories AB (PUBL), Jun 19, 2019 |