RayStation 8B Software Recalled for Pitch and Roll Correction Errors
RaySearch Laboratories is recalling one RayStation 8B software system in Tennessee due to a defect that causes incorrect position 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 involves a medical device software defect that could lead to incorrect treatment planning parameters. Per the rubric, this is classified as High (3) because it is 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 8B Service Pack 2, Build Number 8.1.2.5, stand-alone software treatment planning system. The recall affects a single system distributed to Tennessee. The product is identified by UDI 07350002010235.
The recall was initiated because of 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, the presence of non-zero pitch or roll causes the lateral, longitudinal, and vertical values propagated to the system to be incorrect.
No specific instructions for consumers or healthcare providers are provided in the source text. Users of the affected software should contact the manufacturer for further guidance on managing the defect.
The recalled product
- Product
- RayStation/RayPlan 8B Service Pack 2, Build Number 8.1.2.5, 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 07350002010235
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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