Notice names this product. RAYSEARCH LABORATORIES AB’s RayCare 2024A SP1 is named in FDA Class II recall Z-2646-2026.
Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies.Agency-reported 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. Identifying details: Software Version 8.0.1.60193, UDI 0735000201083920240906, Expiration Date: 2030-01-24. Units affected: 3 units. Status: Ongoing.
1. Compare your item
This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.
Product named
RayCare 2024A SP1
Company / brand
RAYSEARCH LABORATORIES AB
Lot / serial / date codes
Software Version 8.0.1.60193, UDI 0735000201083920240906, Expiration Date: 2030-01-24
Distribution
Worldwide - US Nationwide distribution.
Agency product description and boundaries
RayCare 2024A SP1. Oncology Information Systems.
Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.
If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.
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,…