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 estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs. The intended users of RayStation shall be clinically qualified radiation therapy staff trained in using the system.
- Recall Initiated
- June 29, 2018
- Terminated
- July 16, 2020
- Recall Number
- Z-2497-2018
- Quantity
- 746
Reason for Recall
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.
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.
Lot / Code Info
Software Versions 4.5.0.19 , 4.5.1.14 , 4.5.2.7 , 4.7.0.15 , 4.7.1.10, 4.7.2.5 , 4.7.3.13 , 4.7.4.4 , 4.7.5.4 , 4.9.0.42 , 5.0.0.37 , 5.0.1.11 , 5.0.2.3 , 6.0.0.24 , 6.1.0.26 , 6.1.1.2 , 6.2.0.7 , 7.0.0.19 , 8.0.0.61
Root Cause
Under Investigation by firm
Action Taken
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- or y width of the primary source is below 0.01 cm or if they differ with more than a factor 2, do not use this beam model for DMLC. Contact RaySearch support for further assistance in adjusting the beam model and identifying potentially affected patients. 3. Please educate physics staff about this issue. 4. Inspect your product and identify all installed units with the above software version number(s), then confirm that you have read and understood this notice by replying to the notification email. The firm plans to resolve the issue in the next version of RayStation/RayPlan, scheduled for market release in 2018 (subject to market clearance in some markets).