RayCare 2024A SP1 Oncology Information System Software Recall
RayCare 2024A SP1 oncology software may lose data if beam set delivery notes are modified simultaneously or updated during treatment sessions, with users not notified of changes.
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 an FDA Class II recall of a medical device (oncology information system) where potential data loss could impact patient treatment data integrity and clinical decision-making. The hazard involves loss of critical clinical information without user notification, which poses a risk of harm even though no specific injuries or illnesses have been reported.
Plain-English summary
RAYSEARCH LABORATORIES AB is recalling RayCare 2024A SP1 (Software Version 8.0.1.60193, UDI 0735000201083920240906) oncology information systems software. The recall addresses beam set delivery note issues in which there is potential data loss if the beam set delivery note is modified simultaneously and/or if a note is updated during a treatment session, and the user is not notified of the change.
The affected software has been distributed nationwide in the United States and worldwide. Affected users should contact RAYSEARCH LABORATORIES AB for guidance on mitigating this issue.
Healthcare providers using RayCare 2024A SP1 should be aware of this potential data loss risk and take appropriate precautions when modifying beam set delivery notes, particularly during active treatment sessions.
The recalled product
- Product
- RayCare 2024A SP1. Oncology Information Systems.
- Manufacturer
- RAYSEARCH LABORATORIES AB
- Hazard
- data-loss
- software-defect
- notification-failure
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)
- Software Version 8.0.1.60193
- UDI 0735000201083920240906
- Expiration Date: 2030-01-24
Distribution
Distributed nationwide across the United States.
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