Data Foundry

Medical device recalls 2023

RayCare 5B and 6A including service packs- An oncology information… — Class II medical device recall Z-0206-2024

Ongoing recall by RAYSEARCH LABORATORIES AB, reported 2023-11-08, distributed in MD, TN. An issue was found in RayCare 5B, 6A, including service packs, where values will not be visible for documents

Recall numberZ-0206-2024
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmRAYSEARCH LABORATORIES AB, Stockholm, N/A, Sweden
Recall initiated2023-09-12
Classified2023-11-01
Reported by FDA2023-11-08
DistributedMD, TN
Quantity2 sytems

Product

RayCare 5B and 6A including service packs- An oncology information system used to support workflows and scheduling, as well as clinical information, planning and treatment management for oncology care Product name (build number): (1)RayCare 5B SP1 (5.1.1.60246); (2)RayCare 5B SP3 (5.1.3.60023); (3) RayCare 6A (6.0.0.60553)

Reason for recall

An issue was found in RayCare 5B, 6A, including service packs, where values will not be visible for documents in a read-only state when opened outside the Documents workspace when using document fields configured with single- or multi-selectable values.

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-0206-2024. 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.