Reported Feb 26, 2025 · Ongoing
Brand Name: RayStation -Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 9.1.0.933,…
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 · Eugeniavagen 18c · Stockholm, N/A · N/A
Is this the product you have?
- Brand NameRayStation -Intended as a Radiation Therapy Treatment
- Planning System Model/Catalog Number
9.1.0.9339.2.0.48310.0.0.115410.0.1.52 and 10.0.2.10
- Software Version
RayStation 9B9B Service Pack 110A10A Service Pack 1 and 2
- Lot codes and dates
- Lot Code
UDI: 0735000201026620191220073500020102972020031007350002010303202005260735000201036520200526
- and 0735000201065520220608 GTIN
07350002010266 and 073500020102970735000201030307350002010365
- and 07350002010655 Serial Numbers
9.1.0.9339.2.0.48310.0.0.115410.0.1.52 and 10.0.2.10
- Software Revisions
RayStation 9B9B Service Pack 110A10A
- Service Pack 1 and 2 Expiration Date2025-06-16
- Lot Code
- Amount recalled
- 1
This recall covers 11 products
The agency filed one notice per product. You are reading one of them; the other 10 are below.
Where it was sold
- Nationwide
Why it was recalled
Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and light ion treatment plans when a HU-to-mass density CT calibration curve used in RayStation version 4.5 to 2024B including some service packs.
This product could cause temporary or reversible health problems — stop using it.
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