TomoHelical and TomoDirect plans in RayStation 6, 7, 8A, 8B, 9A, 9B, 10A, 10B and 11A. Build Numbers: 6.1.1.2, 6.2.0.7, 6.3.0.6, 7.0.0.19, 8.0.0.61, 8.0.1.10, 8.1.0.47, 8.1.1.8, 8.1.2.5, 9.0.0.113, 9.1.0.933, 9.2.0.483, 10.0.0.1154, 10.0.1.52, 10.1.0.613, 11.0.0.951 or 11.0.1.29.
Check against the official notice below — it lists the full affected range.
RaySearch Laboratories AB is recalling RayStation radiation treatment planning software versions 6 through 11A distributed to 51 licensed facilities across 15 U.S. states. The software has a defect in its TomoHelical and TomoDirect treatment planning features: when users employ dynamic jaw mode and continue optimization after changing the dose grid or modifying the target region of interest, the jaw positions may shift unexpectedly at certain control points, potentially causing unnecessary jaw openings during treatment planning.
The affected software versions include RayStation 6.1.1.2, 6.2.0.7, 6.3.0.6, 7.0.0.19, 8.0.0.61, 8.0.1.10, 8.1.0.47, 8.1.1.8, 8.1.2.5, 9.0.0.113, 9.1.0.933, 9.2.0.483, 10.0.0.1154, 10.0.1.52, 10.1.0.613, 11.0.0.951, and 11.0.1.29, distributed in Alabama, California, Florida, Georgia, Iowa, Illinois, Missouri, Mississippi, North Carolina, Oklahoma, Oregon, South Carolina, Tennessee, Washington, and Wisconsin. The recall source does not specify what remedy affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
If the dynamic jaw mode is used and an optimization is continued after changing the dose grid or modifying the target ROI, the positions of the jaws may change unexpectedly for some control points. User must be aware to avoid unnecessary jaw openings during treatment planning
Reason for recall: If the dynamic jaw mode is used and an optimization is continued after changing the dose grid or modifying the target ROI, the positions of the jaws may change unexpectedly for some control points. User must be aware to avoid unnecessary jaw openings during treatment planning Distribution: US Nationwide distribution in the states of AL, CA, FL, GA, IA, IL, MO, MS, NC, OK, OR, SC, TN, WA, WI. Quantity: 51 (US) Licenses Lot/code info: Name (build number) UDI-DI: RayStation 6/RayPlan 2 Service Pack 1 (6.1.0.26) 07350002010037 RayStation 6/RayPlan 2 Service Pack 1 v.6.1.1 (6.1.1.2) 07350002010082 RayStation 6/RayPlan 2 Service Pack 2 (6.2.0.7) 07350002010075 RayStation 6/RayPlan 2 Service Pack 3 (6.3.0.6) 07350002010242 RayStation/RayPlan 7 (7.0.0.19) 07350002010068 RayStation/RayPlan 8A (8.0.0.61) 07350002010112 RayStation/RayPlan 8A Service Pack 1 (8.0.1.10) 07350002010136 RayStation/RayPlan 8B (8.1.0.47) 07350002010129 RayStation/RayPlan 8B Service Pack 1 (8.1.1.8) 07350002010204 RayStation/RayPlan 8B Service Pack 2 (8.1.2.5) 07350002010235 RayStation 9A (9.0.0.113) 07350002010174 RayStation 9B (9.1.0.933) 07350002010266 RayStation Service Pack 1 (9.2.0.483) 07350002010297 RayStation 10A (10.0.0.1154) 07350002010303 RayStation 10A Service Pack 1 (10.0.1.52) 07350002010365 RayStation 10B (10.1.0.613) 07350002010310 RayStation 11A (11.0.0.951) 07350002010389 RayStation 11A Service Pack 1 (11.0.1.29) 07350002010433
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.