RayStation Software Recalled for Treatment Record Import and Display Issues
RaySearch Laboratories AB is recalling RayStation standalone software due to issues with treatment record imports and gantry angle display.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences, or where the probability of serious adverse health consequences is remote. No injuries or illnesses are reported in the source text.
Plain-English summary
RaySearch Laboratories AB is recalling RayStation standalone software treatment planning systems, including versions 8A, 8B, 9A, and 9B. The recall involves 12 units distributed to one consignee in Nashville and one consignee in Belgium.
The recall was initiated because it is not obvious that manually importing a treatment record into RayCare PACS does not automatically import the same data into RayTreat. Additionally, there is an issue with the display of planned and recorded Gantry Angle in the delivered beam list in RayTreat.
Affected software versions include 8.0.0.61, 8.0.1.10, 8.1.0.47, 8.1.1.8, 8.1.2.5, 9.0.0.113, 9.1.0.933, and 9.2.0.483. Users should contact the manufacturer for further instructions regarding the software update or correction.
The recalled product
- Product
- RayStation standalone software treatment planning system (RayStation 8A, 8B, 9A, and 9B, including all service packs) model no. 8.0, 8.1, 9.0, 9.1, 9.2
- Manufacturer
- RAYSEARCH LABORATORIES AB
- Category
- Medical Device — Software
- Affected units
- 12
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 (7)
- Software versions 8.0.0.61
- 8.0.1.10
- 8.1.0.47
- 8.1.1.8
- 8.1.2.5
- 9.0.0.113
- 9.1.0.933 and 9.2.0.483
Distribution
Distribution scope not specified by the agency.
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