RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6 and RayStation 7, a stand-alone software treatment planning system.
- Recall Initiated
- September 21, 2018
- Terminated
- June 16, 2020
- Recall Number
- Z-0294-2019
- Quantity
- 110 units
Reason for Recall
Robust optimization for plans using beam set + background dose is not supported in RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6 and RayStation 7.
Distribution
Nationwide
Lot / Code Info
Software, include version number: 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 , 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
Root Cause
Software design
Action Taken
Ray Search Labs notified userson 9/21/18 by email advising users of the action to be taken: After creating an adaptive plan from a plan with robust objectives, remove all robust objectives that are automatically added to the adaptive plan and replace them with other appropriate objectives before optimizing the adapted plan. o Do not use an optimization function template with robust functions for a dependent beam set.o Do not use scripting to add robust optimization functions related to beam set + background dose. Reply form to be completed/signed and returned. Regulatory information, please contact quality@raysearchlabs.com