Medical Device Software Defects in RayStation Treatment Planning System
RayStation radiation therapy treatment planning software versions 6 through 10A contain defects that may cause misleading dose evaluations and contouring errors. Healthcare facilities should verify treatment plans and contact the manufacturer for guidance.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 involving software defects in a critical treatment-planning tool. While no illnesses or injuries have been reported, the defects affect dose calculation and contouring, which are essential functions that directly impact patient treatment accuracy in cancer care.
Plain-English summary
RayStation is a treatment planning system used by cancer centers to design radiation therapy. The recall affects versions 6.0.0.24 through 10.1.0.613 of RayStation and related RayPlan software, with approximately 13,722 systems deployed domestically across the United States and internationally.
The software contains two defects. First, when clinical goals are edited, the evaluation of dose distributions may become misleading. Second, contouring functions may produce errors when the spacing between image slices is 1 millimeter or less. These defects could affect treatment planning accuracy.
Healthcare facilities using affected RayStation versions should verify the accuracy of their treatment plans and contact RaySearch Laboratories for a software update or additional guidance on managing this issue.
The recalled product
- Product
- RayStation (Treatment Planning System) Model Number RayStation is 6.0.0.24 , 6.1.1.2 , 6.2.0.7 , 6.3.0.6 , 7.0.0.19 , 8.0.0.6 , 8.0.1.10 , 8.1.0.47 , 8.1.1.8 , 8.1.2.5 , 9.0.0.113 , 9.1.0.933 , 9.2.0.483 , 10.0.0.1154 , 10.0.1.52 or 10.1.0.613 .
- Manufacturer
- RAYSEARCH LABORATORIES AB
- Affected units
- 13,722
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 (9)
- Software version: RayStation 6
- 7
- 8A
- 8B
- 9A
- 9B
- 10A
- 10B
- RayPlan 2 including some service packs.
Distribution
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