⚠ Data freshness notice: the most recent refresh of NHTSA was incomplete, so a
very recent recall may be missing. Everything shown is accurate as of the last checked time on this page —
for anything time-critical, confirm with the official sources linked below.
FDAClass II · Medical device · Recalled July 8, 2026
RayCare 2024A SP1 recall — RAYSEARCH LABORATORIES AB
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.
Class II: may cause temporary or medically reversible health consequences.
View the official FDA enforcement record (openFDA) ↗
- Official recall ID
- Z-2646-2026
- Brand
- RAYSEARCH LABORATORIES AB
- Classification
- Class II
- Units affected
- 3 units
- Recall status
- Ongoing
- Initiated
- Voluntary: Firm initiated
Description
RayCare 2024A SP1. Oncology Information Systems.
Affected products
Companies & origin
- Recalling firm location
- Stockholm, N/A, Sweden
- Firm address
- Eugeniavagen 18c, N/A, N/A
Identifying details (verbatim from the notice)
- Product codes / lots
- Software Version 8.0.1.60193, UDI 0735000201083920240906, Expiration Date: 2030-01-24
- Distribution
- Worldwide - US Nationwide distribution.
- Firm notified the public via
- N/A
- FDA event ID
- 99141
- Recall initiated
- May 20, 2026
- FDA classified
- July 1, 2026
- FDA report date
- July 8, 2026
Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim;
the linked government source is authoritative. Source last checked July 23, 2026 at 11:04 PM UTC.
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