RayStation Software Recall Due to Potential Data Synchronization Errors
RaySearch Laboratories is recalling RayStation software versions 9A, 9B, 10A, and 10B because flags edited in RayCare may not update in RayTreat.
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, and the source text describes a potential software synchronization error without reporting any specific injuries, illnesses, or deaths, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
RaySearch Laboratories AB is recalling specific versions of RayStation software, including models 9A, 9B, 10A, and 10B, along with their associated service packs. The recall is limited to systems distributed in the state of Tennessee.
The recall was initiated because flags edited in the RayCare system after a patient has been checked in may not always be updated in the RayTreat system. This potential data synchronization issue could affect the accuracy of patient information during treatment planning.
Healthcare facilities using the affected software versions in Tennessee should contact RaySearch Laboratories for further instructions on how to resolve the issue.
The recalled product
- Product
- RayStation Model Number: (9A)9.0.0.113, 9B (9.1.0.933), 9B Service pack (9.2.0.483), 10A (10.0.0.1154), 10A Service pack (10.0.1.52), 10B (10.1.0.613)
- 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 (4)
- Software version: 9A
- 9B
- 10A
- 10B
Distribution
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