RayStation 8A Software Recalled for Treatment Planning Calculation Errors
RaySearch Laboratories is recalling RayStation/RayPlan 8A software due to a defect that causes incorrect treatment planning values when pitch or roll corrections are applied.
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: The recall is classified as FDA Class II and involves a medical device software defect that could lead to incorrect treatment planning values. This fits the rubric for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
RaySearch Laboratories AB is recalling one unit of the RayStation/RayPlan 8A stand-alone software treatment planning system, Build Number 8.0.0.61. The recall is classified as Class II by the U.S. Food and Drug Administration.
The recall is due to a potential for erroneous propagation of current tabletop positions when applying pitch or roll corrections. The source text notes that while pitch and roll corrections are not propagated, non-zero pitch or roll values cause the lateral, longitudinal, and vertical values propagated to the system to be incorrect.
The affected product was distributed to the state of Tennessee. The UDI for the recalled unit is 07350002010112. Users of this software should contact the manufacturer for further instructions regarding the defect.
The recalled product
- Product
- RayStation/RayPlan 8A, Build Number 8.0.0.61, 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 07350002010112
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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