FDA DevicesClass II
RayCare 2024A SP1. Oncology Information Systems.
Published: July 8, 2026Recall ID: Z-2646-2026Category: devicesCountry: US
Reason for Recall / Hazard
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.
Product Description & Identification
RayCare 2024A SP1. Oncology Information Systems.
Additional Source Details
| Field | Value |
|---|---|
| City | Stockholm |
| State | N/A |
| Event id | 99141 |
| Address 1 | Eugeniavagen 18c |
| Address 2 | N/A |
| Code info | Software Version 8.0.1.60193, UDI 0735000201083920240906, Expiration Date: 2030-01-24 |
| Postal code | N/A |
| Report date | 20260708 |
| Product type | Devices |
| Product quantity | 3 units |
| Reason for recall | 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260520 |
| Initial firm notification | N/A |
| Center classification date | 20260701 |
Overview
- Recalling FirmRAYSEARCH LABORATORIES AB
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide - US Nationwide distribution.