OVERLOOKED

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Class IIOngoing

RAYSEARCH LABORATORIES AB recalls 2 products

Recall date · record updated Jul 8, 2026 · Source: U.S. Food and Drug Administration (openFDA device enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
RAYSEARCH LABORATORIES AB
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.
Hazard
FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).
Who’s affected
Worldwide - US Nationwide distribution.
Where
Nationwide
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99141…

Products (2)

  1. RayCare 2024A SP1. Oncology Information Systems.

    Codes/lots: Software Version 8.0.1.60193, UDI 0735000201083920240906, Expiration Date: 2030-01-24Quantity: 3 unitsRecall no. Z-2646-2026Class II

  2. RayCare 2024A SP4. Oncology Information Systems.

    Codes/lots: Software Version 8.0.4.60077, UDI 0735000201089120241218, Expiration Date: 2030-01-24.Quantity: 3 unitsRecall no. Z-2647-2026Class II

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

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