RayCare 2024A SP1. Oncology Information Systems.
FDA device recall Z-2646-2026 · posted 2026-07-01 · Open, Classified
Recall details
- Recalling firm
- RAYSEARCH LABORATORIES AB
- 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.
- Action taken
- A Field Safety Notice, Medical Device Correction #175428 dated 6/2/26 was emailed to consignees. The notice advises consignees to ensure clear verbal or procedural communication when updating the beam set delivery note, avoid making changes from any location other than the control room when treatment is ongoing, avoid relying on beam set delivery note for conveying critical information. Additionally, consignees are to ensure planning staff and users are educated of the provided workaround. Consignees are to verify the software version of their units and reply to the emailed notification. A software update is scheduled for August 2026 to address this issue. Consignees with questions can contact quality@raysearchlabs.com.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- MUJ
- Quantity affected
- 3 units
- Distribution
- Worldwide - US Nationwide distribution.
- Date initiated
- 2026-05-20
- Date posted
- 2026-07-01
- Location
- Stockholm, Sweden
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| RayCare (2024A SP1) (K242992) | RaySearch Laboratories AB (PUBL) | 2025-04-17 |