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Recall Observatory FDA recall evidence

Device product

RayCare 2024A SP1. Oncology Information Systems.

Z-2646-2026

May 20, 2026

Class II

Product summary

Firm
RAYSEARCH LABORATORIES AB
Event
Event 99141
Status
Ongoing
Classification
Class II
Quantity
3 units
Official record key
device-enforcement:Z-2646-2026

Official wording

Reason: 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.

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

Distribution pattern: Worldwide - US Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.