RayCare 2024A SP4. Oncology Information Systems. recall (RAYSEARCH LABORATORIES AB)
Medical deviceClass IIOngoing
Summary: RAYSEARCH LABORATORIES AB is recalling RayCare 2024A SP4. Oncology Information Systems.. Reason: 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 is being recalled
RayCare 2024A SP4. Oncology Information Systems.
Why
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.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
Worldwide - US Nationwide distribution.
How to tell if yours is affected
Software Version 8.0.4.60077, UDI 0735000201089120241218, Expiration Date: 2030-01-24.
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2647-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | May 20, 2026 |
| Reported | July 8, 2026 |
| Company | RAYSEARCH LABORATORIES AB |
| Company location | Stockholm, N/A, Sweden |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 3 units |
More recalls from RAYSEARCH LABORATORIES AB · all medical device recalls · recalls from May 2026