RayCare 2024A SP1 and RayCare 2024A SP4 oncology information system software (Software Version 8.0.1.60193, UDI 0735000201083920240906; Software Version 8.0.4.60077, UDI 0735000201089120241218) sold worldwide including US nationwide distribution (3 units) are affected. They were recalled because beam set delivery notes can suffer potential data loss if a note is modified simultaneously or updated during a treatment session and the user is not notified of the change.
What's being recalled
RayCare 2024A SP1. Oncology Information Systems.
RayCare 2024A SP4. Oncology Information Systems.
Recalling firm: Raysearch Laboratories Ab, Stockholm, N/A, Sweden.
How to identify it
Software Version 8.0.1.60193, UDI 0735000201083920240906, Expiration Date: 2030-01-24 Software Version 8.0.4.60077, UDI 0735000201089120241218, Expiration Date: 2030-01-24.
The hazard
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, the user is not notified of the change.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Worldwide - US Nationwide distribution.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)