RayStation Software Recall for Potential Treatment Planning Errors
RaySearch Laboratories is recalling one RayStation 8A system in Tennessee due to a software defect that may cause incorrect treatment planning calculations.
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: The recall is classified as FDA Class II and involves a medical device software defect that could lead to incorrect treatment planning, representing a risk of harm where injury has not yet been reported.
Plain-English summary
RaySearch Laboratories AB is recalling one unit of the RayStation/RayPlan 8A Service Pack 1, Build Number 8.0.1.10, stand-alone software treatment planning system. The recall affects a single system distributed to the state of Tennessee, identified by UDI 07350002010136.
The recall was initiated because of a potential software defect involving the propagation of tabletop positions. Specifically, when pitch or roll correction is applied, non-zero pitch or roll values can cause the lateral, longitudinal, and vertical values to be calculated incorrectly. This error could lead to inaccurate treatment planning.
Users of the affected software should contact RaySearch Laboratories AB for further instructions on how to resolve the issue. The agency has classified this as a Class II recall, indicating that use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- RayStation/RayPlan 8A Service Pack 1, Build Number 8.0.1.10, stand-alone software treatment planning system
- Manufacturer
- RAYSEARCH LABORATORIES AB
- Category
- Medical Device — Software
- Affected units
- 1
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 (1)
- UDI 07350002010136
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 7 recalled by RAYSEARCH LABORATORIES AB under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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