FDA Device recall Z-2646-2026
RayCare 2024A SP1. Oncology Information Systems
- FDA Device
- Class II
- ongoing
- Published 2026-07-08
On 2026-07-08 the FDA classified a Class II recall of RayCare 2024A SP1. Oncology Information Systems by Raysearch Laboratories Ab, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2646-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-05-20 |
| Published | 2026-07-08 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Raysearch Laboratories Ab |
| Distribution | US |
Product
RayCare 2024A SP1. Oncology Information Systems.
Reason
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.
Identifiers
| code_info | Software Version 8.0.1.60193, UDI 0735000201083920240906, Expiration Date: 2030-01-24 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2646-2026%22
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