Recall Z-1310-2015 ยท MUJ System, Planning, Radiation Therapy Treatment
RAYSEARCH LABORATORIES AB
RayStation Radiation Therapy Treatment Planning System; -- RayStation 3.5, RayStation 4.0, RayStation 4.5 and RayStation 4.7. For RayStation 4.7, the issue applies also to machines with fixed jaws, regardless of MLC/jaw position. RayStation is a software system designed for treatment planning and analysis of radiation therapy.
| Date | Mar 20, 2015 (initiated Mar 4, 2015) |
| Status | Terminated |
| Reason | An issue with photon dose calculation for DMLC (Dynamic MLC) plans for machines where the MLC is positioned above the jaws, e.g. some Elekta linacs. The magnitude of the error depends on the beam model output factor corrections and on the individual DMLC plan characteristics. |
| Root cause | Under Investigation by firm |
| Action | The firm, Raysearch Laboratories, sent a "Medical Device Correction/Field Safety Notice" and Reply Form(dated 3/3/2015) on 3/4/2015 via e-mail to the affected customers. The notice describes the product, problem and actions to be taken. The customers were instructed to deprecate any beam models that have been commissioned as DMLC capable for the affected linac types; do not commission beam models as DMLC capable for the affected linac types; educate physics staff and all users; inspect your system and identify all affected units of RayStation, acknowledge this notice by email or complete and |
| Quantity | Domestic: 245 units |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141860 | RAYSTATION Raysearch Laboratories AB, Oct 23, 2014 |