RayCare Oncology Software Recalled for Offline Image Review Error
RaySearch Laboratories AB is recalling RayCare oncology software due to an error message that may prevent users from accessing offline images during review tasks.
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 software error that may impede workflow but does not report any injuries, illnesses, or deaths, fitting the criteria for a moderate severity recall.
Plain-English summary
RaySearch Laboratories AB is recalling RayCare stand-alone software, which is used to support workflows, scheduling, and clinical information management for oncology care. The recall involves specific software versions (2.2.2.30782, 2.2.3.53423, 3.0.1.43597, 3.1.0.60341, and 4.0.0.60621) and models (2C SP2, 2C SP3, 3A SP1, 3B, and 4A).
The recall is issued because an error message stating "Review files not available" may be displayed when performing offline image review in RayCare 2C, 3A, and 3B. This error can occur when the software attempts to guide the user to the image viewer with the treatment image related to the fraction and the planning image selected.
The affected software was distributed nationwide in the United States, including in the state of Tennessee. Users of the affected software versions should contact RaySearch Laboratories AB for further instructions on how to resolve the issue.
The recalled product
- Product
- RayCare, device is stand-alone software - Product Usage: used to support workflows and scheduling, as well as clinical information, planning and treatment management for oncology care.
- Manufacturer
- RAYSEARCH LABORATORIES AB
- Category
- Medical Device — Software
- Hazard
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 (8)
- Model #: 2C SP2
- 2C SP3
- 3A SP1
- 3B and 4A Software Version: 2.2.2.30782
- 2.2.3.53423
- 3.0.1.43597
- 3.1.0.60341
- 4.0.0.60621"
Distribution
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