RayStation 9B Software Recalled for Pitch and Roll Correction Errors
RaySearch Laboratories AB is recalling one RayStation/RayPlan 9B software system in Tennessee due to potential errors in position calculations during pitch or roll corrections.
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 with a defect that could lead to incorrect treatment planning parameters, 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 9B, Build Number 9.1.0.933, stand-alone software treatment planning system. The recall affects a single system distributed to the state of Tennessee. The product is identified by UDI 07350002010266.
The recall was initiated because there is a potential for erroneous propagation of current tabletop positions when applying pitch or roll corrections. Specifically, while pitch and roll corrections are not propagated, the presence of non-zero pitch or roll values causes the lateral, longitudinal, and vertical values to be calculated incorrectly.
No specific instructions for consumers are provided in the source text, but the recall is limited to the single identified system in the United States.
The recalled product
- Product
- RayStation/RayPlan 9B, Build Number 9.1.0.933, stand-alone software treatment planning system
- Manufacturer
- RAYSEARCH LABORATORIES AB
- Category
- Medical Device — Software
- Hazard
- 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 07350002010266
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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