Reported Apr 6, 2022 · Terminated
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,…
Raysearch Laboratories Ab
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: RAYSEARCH LABORATORIES AB · Sveavagen 9 · Stockholm, N/A · N/A
Is this the product you have?
- TomoHelical and TomoDirect plans in RayStation 6, 7, 8A, 8B, 9A, 9B, 10A, 10B and 11A
- Build Numbers
6.1.1.26.2.0.76.3.0.67.0.0.198.0.0.618.0.1.108.1.0.478.1.1.88.1.2.59.0.0.1139.1.0.9339.2.0.48310.0.0.115410.0.1.5210.1.0.61311.0.0.951 or 11.0.1.29
- Lot codes and dates
- Name (build number) UDI-DIRayStation 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
- Amount recalled
- 51 (US) Licenses
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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