FDA-Device2026-07-08Class II

RayCare 2024A SP1. Oncology Information Systems.

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.

Sold states
Worldwide - US Nationwide distribution.
Affected count
3 units
Manufactured in
Eugeniavagen 18c, N/A, Stockholm, N/A, Sweden
Products
RayCare 2024A SP1. Oncology Information Systems.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2646-2026

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