RAYSEARCH LABORATORIES AB recalls RayCare 2024A SP4. Oncology Information Systems.

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.

A Field Safety Notice, Medical Device Correction #175428 dated 6/2/26 was emailed to consignees. The notice advises consignees to ensure clear verbal or procedural communication when updating the beam set delivery note, avoid making changes from any location other than the control room when treatment is ongoing, avoid relying on beam set delivery note for conveying critical information. Additionally, consignees are to ensure planning staff and users are educated of the provided workaround. Consignees are to verify the software version of their units and reply to the emailed notification. A software update is scheduled for August 2026 to address this issue. Consignees with questions can contact quality@raysearchlabs.com.

• FDA enforcement recordOfficial FDA database entry for Z-2647-2026
• FDA 510(k) clearance · K242992The 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.