FDA Recall Terminated

RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6 and RayStation 7, a stand-alone software treatment planning system.

Recall: Z-0294-2019 · Initiated September 21, 2018

Recall

Recall Number
Z-0294-2019
Event Number
81269
Firm
RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden
FEI Number
3007774465
Product Code
MUJ
Status
Terminated
Root Cause
Software design
Initiated
September 21, 2018
Terminated
June 16, 2020

Description

RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6 and RayStation 7, a stand-alone software treatment planning system.

Reason

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.

Action

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 [email protected]

Distribution

Nationwide

Quantity

110 units