Recalling firm
RAYSEARCH LABORATORIES AB
Product type
Device
Status
Ongoing
Report date
2026-07-08
Distribution
Worldwide - US Nationwide distribution.
Firm state
N/A
Product quantity
3 units
Initiated by
Voluntary: Firm initiated
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.
Product description
RayCare 2024A SP1. Oncology Information Systems.
Code / lot info
Software Version 8.0.1.60193, UDI 0735000201083920240906, Expiration Date: 2030-01-24
Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.