Raysearch Laboratories Ab: System, Planning, Radiation Therapy Treatment

RayCare 2024A SP4 Recall Summary RaySearch Laboratories is recalling RayCare 2024A SP4, a radiation therapy planning system used in cancer treatment, due to potential data loss in beam set delivery notes. The problem occurs when delivery notes are modified at the same time or updated during an active treatment session, and users may not be alerted to these changes. This recall affects hospitals and cancer centers nationwide that use this software.

Recalling firm
RAYSEARCH LABORATORIES AB
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.
Classification
Class II
Category
medical device recall
Country
United States
Agency
FDA-DEVICES
Recall date
2026-05-20
Status
Open, Classified
Areas affected
AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
Distribution
Worldwide - US Nationwide distribution.

Official recall notice from FDA-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/e8ca4c94-f1ab-4c40-924b-71b35759b55d