RayStation 8B Software Recalled for Pitch and Roll Correction Errors
RaySearch Laboratories is recalling one RayStation 8B treatment planning system in Tennessee due to a software error that may cause incorrect position values.
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 involves a medical device software defect that could lead to incorrect treatment planning values, representing a risk of harm where injury has not yet been reported.
Plain-English summary
RaySearch Laboratories AB is recalling one stand-alone RayStation/RayPlan 8B Service Pack 1 software treatment planning system in the United States. The affected system is located in Tennessee and has the UDI 07350002010204.
The recall is due to a potential software error where applying pitch or roll correction may cause the lateral, longitudinal, and vertical values to be incorrect. This issue occurs even though pitch and roll corrections are not intended to be propagated.
Healthcare providers should contact RaySearch Laboratories for instructions on how to resolve the issue. No injuries or illnesses have been reported in connection with this recall.
The recalled product
- Product
- RayStation/RayPlan 8B Service Pack 1, Build Number 8.1.1.8, stand-alone software treatment planning system
- Manufacturer
- RAYSEARCH LABORATORIES AB
- 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 07350002010204
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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