RayCare — Class II medical device recall Z-2899-2020
Ongoing recall by RAYSEARCH LABORATORIES AB, reported 2020-09-02, distributed nationwide. When performing offline image review in RayCare 2C, RayCare 3A and RayCare 3B an offline image review task wil
| Recall number | Z-2899-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | RAYSEARCH LABORATORIES AB, Stockholm, N/A, Sweden |
| Recall initiated | 2020-07-29 |
| Classified | 2020-08-27 |
| Reported by FDA | 2020-09-02 |
| Distributed | Nationwide (US) |
| Model numbers | SP1, SP2, SP3 |
Product
RayCare, device is stand-alone software - Product Usage: used to support workflows and scheduling, as well as clinical information, planning and treatment management for oncology care.
Reason for recall
When performing offline image review in RayCare 2C, RayCare 3A and RayCare 3B an offline image review task will guide you to the image viewer with the treatment image related to the fraction and the planning image selected. When starting the task, an error message might be displayed stating: Review files not available.
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-2899-2020. 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.