Reported Feb 26, 2025 · Ongoing
Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 13.0.0.1547,…
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
13.0.0.154713.1.0.14413.1.1.89 and 14.0.0.3338
- Software Version
RayStation 12A12A Service Pack 1 and 2 and 2023B
- Lot codes and dates
- Lot Code
UDI: 073500020105492022061607350002010679202210070735000201073020230913
- and 0735000201055620230630 GTIN
073500020105490735000201067907350002010730
- and 07350002010556 Serial Numbers
13.0.0.154713.1.0.14413.1.1.89 and 14.0.0.3338
- Software Revisions
RayStation 12A12A Service
- Pack 1 and 2 and 2023B Expiration Date2028-07-07
- Lot Code
- Amount recalled
- 32
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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