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

RayCare 2024A SP1

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 24, 2026 at 12:00 AM UTC.

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