RayCare software — Class II medical device recall Z-2464-2023
Ongoing recall by RAYSEARCH LABORATORIES AB, reported 2023-09-06, distributed nationwide. An issue was found in Software RayCare 5A, 5B, 6A, including service packs, where an allergy warning against m
| Recall number | Z-2464-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | RAYSEARCH LABORATORIES AB, Stockholm, N/A, Sweden |
| Recall initiated | 2023-07-17 |
| Classified | 2023-08-25 |
| Reported by FDA | 2023-09-06 |
| Distributed | Nationwide (US) |
| Quantity | 1 install |
| Reason classes | software |
| Model numbers | 5.0.0, 5.0.1, 5.1.1, 5.1.2, 5.1.3, 6.0.0 |
Product
RayCare software, include version number 5A, 5B, 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. Model Numbers: 5.0.0, 5.0.1, 5.1.1,5.1.2, 5.1.3, 6.0.0
Reason for recall
An issue was found in Software RayCare 5A, 5B, 6A, including service packs, where an allergy warning against medication substance (drug ingredient) will not be displayed as expected under certain circumstances
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-2464-2023. 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.