RAYSEARCH LABORATORIES AB: RayCare 2024A SP1. Oncology Information Systems.
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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- RAYSEARCH LABORATORIES AB
- Product
- RayCare 2024A SP1. Oncology Information Systems.
- Reason / 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.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- Worldwide - US Nationwide distribution.
- Recall initiated
- 2026-05-20
- Code info
- Software Version 8.0.1.60193, UDI 0735000201083920240906, Expiration Date: 2030-01-24
- Product quantity
- 3 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Stockholm
- State
- N/A
- Country
- Sweden
- Event id
- 99141
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