RayStation radiation therapy software: incorrect density uncertainty calculations in dose planning
RayStation radiation therapy planning software versions 4.5 through 2024B contains an inconsistency in density uncertainty calculations affecting proton and light ion dose computations. No illnesses reported.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall affecting dose calculation accuracy in radiation therapy planning. No illnesses, injuries, or deaths reported in source text, but the theoretical hazard of incorrect dose calculations in treatment planning qualifies as high-risk.
Plain-English summary
RayStation is a radiation therapy treatment planning system used to calculate radiation doses for patient treatments. The recall affects RayStation software versions 4.5 through 2024B, including specific service packs.
The issue involves an inconsistency in how the software handles density uncertainty when using HU-to-mass density CT calibration curves. This inconsistency affects three functions: Robust optimization, Robust evaluation, and Compute perturbed dose, specifically when planning proton and light ion treatments. Incorrect density calculations could lead to inaccurate dose computations.
The affected software has been distributed worldwide, including throughout the United States, Australia, Austria, Belgium, Canada, China, Denmark, France, Germany, Hong Kong, India, Italy, Japan, Korea, Netherlands, Norway, Poland, Singapore, Spain, Switzerland, Taiwan, Thailand, and the UK.
Healthcare facilities using affected RayStation versions should contact RaySearch Laboratories AB for information about updates or mitigations. Clinics should review treatment plans created with the affected versions to ensure clinical safety.
The recalled product
- Product
- Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 12.0.0.932, 12.1.0.1221, 12.0.3.68, 12.0.4.12 and 12.3.0.119 Software Version: RayStation 11B and 11B Service Pack 1, 2, 3 and Service Pack Toshiba 1
- Manufacturer
- RAYSEARCH LABORATORIES AB
- Hazard
- radiation-dose-error
- calibration-error
- software-inconsistency
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (11)
- Lot Code: UDI: 0735000201042620211208
- 0735000201049520220312
- 0735000201050120220422
- 0735000201060020220620 and 0735000201057020221222 GTIN: 07350002010426
- 07350002010495
- 07350002010501
- 07350002010600 and 07350002010570 Serial Numbers: 12.0.0.932
- 12.1.0.1221
- 12.0.3.68
- 2
- 3 and Service Pack Toshiba 1 Expiration Date: 2028-03-20
Distribution
Distributed nationwide across the United States.
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