RayStation Radiation Therapy Planning Software Recall for Density Calculation Inconsistency
RayStation radiation therapy planning software contains an inconsistency in how it calculates density uncertainty for proton and light ion treatments. This affects versions 4.5 through 2024B and could impact treatment plan accuracy.
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: This is an FDA Class II medical device recall affecting radiation therapy planning software. No hospitalizations or injuries are reported in the source documentation. The issue involves a software calculation inconsistency that could affect treatment plan accuracy in proton and light ion therapies, constituting a risk-of-harm situation without reported incidents.
Plain-English summary
RayStation is a radiation therapy treatment planning system used in medical facilities to calculate and optimize cancer treatment doses. Affected versions are RayStation 4.5 through 2024B, including specific software revisions (12A, 12A Service Pack 1, 12A Service Pack 2, and 2023B).
The recall addresses an inconsistency in how the software calculates density uncertainty in three critical functions: Robust Optimization, Robust Evaluation, and Compute Perturbed Dose. This inconsistency occurs when a HU-to-mass density CT calibration curve is used in treatment planning for proton and light ion therapies.
Worldwide distribution includes medical facilities in the United States and 23 other countries, with 32 systems affected overall. Locations include Australia, Austria, Belgium, Canada, China, Denmark, France, Germany, Hong Kong, India, Italy, Japan, Korea, Netherlands, Norway, Poland, Singapore, Spain, Switzerland, Taiwan, Thailand, and the United Kingdom.
Facilities using affected RayStation versions should review their treatment planning procedures and contact RaySearch Laboratories AB or the FDA for information about corrections or updates.
The recalled product
- Product
- Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 13.0.0.1547, 13.1.0.144, 13.1.1.89 and 14.0.0.3338 Software Version: RayStation 12A, 12A Service Pack 1 and 2 and 2023B
- Manufacturer
- RAYSEARCH LABORATORIES AB
- Hazard
- dose-calculation-error
- calculation-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 (8)
- Lot Code: UDI: 0735000201054920220616
- 0735000201067920221007
- 0735000201073020230913 and 0735000201055620230630 GTIN: 07350002010549
- 07350002010679
- 07350002010730 and 07350002010556 Serial Numbers: 13.0.0.1547
- 13.1.0.144
- 13.1.1.89 and 14.0.0.3338 Software Revisions: RayStation 12A
- 12A Service Pack 1 and 2 and 2023B Expiration Date: 2028-07-07
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- HighMedtronic DLP Retrograde Cannula cardiopulmonary bypass catheter
FDA (Devices) · 2026-05-27
- HighSwan-Ganz Jr Catheter models recalled due to lumen hub leakage
FDA (Devices) · 2026-05-27
- HighAzurion X-ray System Deaeration Hose May Degrade and Cause Oil Leakage
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula Cardiopulmonary Bypass Catheter Recall
FDA (Devices) · 2026-05-27
- HighPhilips Azurion X-Ray Systems Table Movement Control Defect Recall
FDA (Devices) · 2026-05-27