Recall Z-2554-2018 ยท MUJ System, Planning, Radiation Therapy Treatment
RAYSEARCH LABORATORIES AB
RayStation Radiation Therapy Treatment Planning System, Model nos. 2.5, 3.5, 4.0, 4.3, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 7.0 Product Usage RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to admi
| Date | Jun 6, 2018 |
| Status | Terminated |
| Reason | The firm has learned that some RayStation/RayPlan users have commissioned machines with erroneous Beam profile correction parameters. These parameters affect the dose calculated in corners of large or off-axis fields. This effect cannot be seen in the Beam Commissioning module and dose in large or off-axis fields needs to be validated using the Beam 3D Modeling module in RayPhysics/RayPlan Physics. The user must be aware to avoid incorrect dose calculations during treatment planning. |
| Root cause | Software design |
| Action | On June 6, 2018, the firm issued an Urgent Field Safety Notice, Medical Device Correction letter to affected customers via email. The notice was a reminder to follow the instructions listed in the product documentation when creating a photon beam model in RayStation/RayPlan. ACTIONS TO BE TAKEN BY THE USER " Always validate the beam model for all clinically relevant fields, including, but not limited to, large and off-axis fields, before the system is used to create clinical treatment plans. " Carefully review all beam model parameters before commissioning. " Be aware that the Beam profile co |
| Quantity | 718 |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K180379 | RayStation 7 RaySearch Laboratories AB (PUBL), Apr 25, 2018 |