Official recall notice
FDA DeviceClass IINotable
FDA Recall: RayCare 2024A SP4. Oncology Information Systems.
- Recall date
- 2026-07-08
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
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.
Product description
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.
Affected products
Software Version 8.0.4.60077, UDI 0735000201089120241218, Expiration Date: 2030-01-24.