FDAFDA recall Z-2646-2026 · Jul 8, 2026
RAYSEARCH LABORATORIES AB: RayCare 2024A SP1 recall
Recall found
Product
RayCare 2024A SP1. Oncology Information Systems.
Reason for recall
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
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- Software Version 8.0.1.60193, UDI 0735000201083920240906, Expiration Date: 2030-01-24
- Quantity
- 3 units
- Distribution
- Worldwide - US Nationwide distribution.
- Recalling firm
- RAYSEARCH LABORATORIES AB, Stockholm, N/A
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-05-20
Source: openFDA enforcement record Z-2646-2026 · search recall number Z-2646-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.