RAYSEARCH LABORATORIES AB recalls RayStation with the following product descriptions: 1. RayStation 11B

DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.

RaySearch notified consignees on about 08/08/2025 via email. Consignees were informed that as temporary solution, affected objects can be re-exported via RayGateway to generate new UIDs. They were instructed to inform planning staff and all users about this workaround, inspect your product and identify all installed units with the above software version number(s), and complete and return the response form. The issue will be resolved in the next version of RayStation, scheduled for market release in December 2025 (subject to market clearance in some markets). If customers wish to continue using versions of RayStation affected by this notice, all users must maintain awareness of this notice. Alternatively, customers can choose to upgrade to the new version once it becomes available for clinical use.

• FDA enforcement recordOfficial FDA database entry for Z-2492-2025
• FDA 510(k) clearance · K220141The device's official FDA premarket clearance record
• FDA device classification · MUJOfficial FDA classification for this device type
• CFR regulation · 21 CFR 892.5050The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find RAYSEARCH LABORATORIES ABSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.