FDAHealthMay 20, 2026

RAYSEARCH LABORATORIES AB — RayCare 2024A SP1. Oncology Information Systems.

⚠️ 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.

Is this relevant to me?

Geography: Nationwide
Source agency: FDA
Category: Health
Published: May 20, 2026

Worldwide - US Nationwide distribution.

What's affected?

Product: RayCare 2024A SP1. Oncology Information Systems.
Brand: RAYSEARCH LABORATORIES AB
Lot code: Software Version 8.0.1.60193, UDI 0735000201083920240906, Expiration Date: 2030-01-24

Additional details

Software Version 8.0.1.60193, UDI 0735000201083920240906, Expiration Date: 2030-01-24

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 3 units.

View original FDA notice →

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