Oncology Information System Document Values Not Visible in Read-Only Mode
RayCare oncology information system versions 5B and 6A contain a software bug where document field values do not display when documents are opened in read-only mode outside the Documents workspace.
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: This is a Class II medical device with a software functionality bug affecting data visibility in an oncology clinical system. Although no injuries or hospitalizations have been reported, the issue represents a risk of harm through incomplete patient information access in a high-stakes medical context where treatment decisions depend on complete clinical data.
Plain-English summary
RayCare 5B (SP1 and SP3) and RayCare 6A are oncology information systems manufactured by RaySearch Laboratories AB. These systems support clinical workflows, scheduling, and treatment planning for oncology care.
A visibility bug was identified in these product versions. When users open documents in read-only mode outside the Documents workspace, and those documents contain fields configured with single- or multi-selectable values, the values for those fields do not display to the user.
This issue affects healthcare facilities in Maryland and Tennessee that use the affected RayCare versions. The incomplete information display could impact clinicians' access to complete patient data during treatment planning and clinical decision-making.
Users of RayCare 5B SP1, 5B SP3, or RayCare 6A should contact RaySearch Laboratories AB regarding a software update to resolve this display issue and ensure full visibility of document field values.
The recalled product
- Product
- RayCare 5B and 6A including service packs- An oncology information system used to support workflows and scheduling, as well as clinical information, planning and treatment management for oncology care Product name (build number): (1)RayCare 5B SP1 (5.1.1.60246); (2)RayCare 5B
- Manufacturer
- RAYSEARCH LABORATORIES AB
- Hazard
- missing-values
- data-visibility
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 (3)
- UDI-DI: (1)RayCare 5B SP1 (5.1.1.60246) 0735000201053220220316
- (2)RayCare 5B SP3 (5.1.3.60023) 0735000201069320221027
- (3) RayCare 6A (6.0.0.60553) 0735000201056320220617
Distribution
Distributed in 2 states:
- MD
- TN
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