Data Foundry

Medical device recalls 2026

RayCare 2024A SP4 — Class II medical device recall Z-2647-2026

Ongoing recall by RAYSEARCH LABORATORIES AB, reported 2026-07-08, distributed nationwide. Beam set delivery note issues in which there is potential data loss if the beam set delivery note is modified

Recall numberZ-2647-2026
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmRAYSEARCH LABORATORIES AB, Stockholm, N/A, Sweden
Recall initiated2026-05-20
Classified2026-07-01
Reported by FDA2026-07-08
DistributedNationwide (US)
Quantity3 units
Expiration dates2030-01-24

Product

RayCare 2024A SP4. Oncology Information Systems.

Reason for recall

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2647-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.