Recall Z-2647-2026— RAYSEARCH LABORATORIES AB

Name: FDA recall Z-2647-2026
Creator: U.S. Food and Drug Administration
Published: 2026-05-20

Class II · Ongoing

Class II FDA medical device recall by RAYSEARCH LABORATORIES AB, initiated 2026-05-20. It names one FDA 510(k) clearance: K242992. Product: 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..

Recalling firm: RAYSEARCH LABORATORIES AB
Classification: Class II
Status: Ongoing
Initiated: 2026-05-20
Firm location: Stockholm, N/A, Sweden

510(k) clearances named in this recall

1 on FDA's record

K242992 — RayCare (2024A SP1)RaySearch Laboratories AB (PUBL)·cleared 2025-04-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

RayCare 2024A SP4. 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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.