Recall Z-2497-2018 ยท MUJ System, Planning, Radiation Therapy Treatment
RAYSEARCH LABORATORIES AB
RayStation stand-alone software treatment planning system, RayStation 4.5, RayStation 4.7, RayStation 4.9 (RayPlan 1), RayStation 5, RayStation 6 (RayPlan 2), RayStation 7 (RayPlan 7) and RayStation 8A (RayPlan 8A) 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 esti
| Date | Jun 29, 2018 |
| Status | Terminated |
| Reason | If the beam model has a highly asymmetric primary source, it is not correctly taken into account in the calculation of DMLC fields when the collimator is rotated. This could lead to potentially significant overdosage at delivery. The user must be aware of the issue to avoid incorrect dose calculations during treatment planning. |
| Root cause | Under Investigation by firm |
| Action | On June 29, 2018, the firm issued an Urgent Field Safety Notice, Medical Device Correction #32484 to affected customers via email. The firm notified customers of the issue with the affected models: If the beam model has a highly asymmetric primary source, it is not correctly taken into account in the calculation of DMLC fields when the collimator is rotated. The user was instructed to do the following: 1. Inspect the beam model for all LINACs with jaw movement per beam, x-jaws and where the MLC is not above both jaws (i.e., Varian style LINACs) that allow DMLC planning. 2. If either the x- |
| Quantity | 746 |
| Distribution | US Nationwide Distribution to accounts in AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, ID, IL, LA, MA, MD, ME, MI, MO, MS, MT, NC, NJ, NV, NY, OH, OK, OR, PA, RI, TN, TX, UT, VA, VT, WA, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K180379 | RayStation 7 RaySearch Laboratories AB (PUBL), Apr 25, 2018 |