FDA recall, , Moderate risk
RaySearch RayCare Oncology Information Systems
Beam set delivery note issues can cause data loss if the note is modified simultaneously or updated during a treatment session.
Summary by Recall Canary from the FDA notice
What happened
RAYSEARCH LABORATORIES AB, of Stockholm, Sweden, began a recall of RayCare 2024A SP1 and RayCare 2024A SP4, Oncology Information Systems, on May 20, 2026. The FDA added the recall to its Enforcement Report and classified it on July 1, 2026. The issue is beam set delivery note problems that can cause data loss if the note is modified simultaneously or updated during a treatment session, with the user not notified of the change. The products were distributed nationwide in the US and worldwide.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
2 products
Compare these details with yours, then check the recall notice to see which units are recalled.
RayCare 2024A SP1. Oncology Information Systems.
RayCare 2024A SP4. Oncology Information Systems.
Recall details
- Company began the recall
- Sold in
Worldwide - US Nationwide distribution.
- Company
- RAYSEARCH LABORATORIES ABStockholm, Sweden
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99141
- Recall numbers
- Z-2646-2026 to Z-2647-2026
All recalls from RAYSEARCH LABORATORIES AB
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
