RayCare 3B — Class II medical device recall Z-1281-2021
Ongoing recall by RAYSEARCH LABORATORIES AB, reported 2021-03-31, distributed nationwide. Patient related messages created in RayCare 3B, RayCare 4A will be lost when upgrading from RayCare 2 to RayCa
| Recall number | Z-1281-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | RAYSEARCH LABORATORIES AB, Stockholm, N/A, Sweden |
| Recall initiated | 2021-03-03 |
| Classified | 2021-03-19 |
| Reported by FDA | 2021-03-31 |
| Distributed | Nationwide (US) |
| Quantity | 1 units |
Product
RayCare 3B (3.1.0.60341) - Product Usage: Intended Use Oncology information system that supports healthcare professionals in delivering cancer care.
Reason for recall
Patient related messages created in RayCare 3B, RayCare 4A will be lost when upgrading from RayCare 2 to RayCare 3B or later
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-1281-2021. 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.