RayStation/RayPlan. Model/Catalog Number: 10.1. Software Version: RayStation/RayPlan 10B. Radiation Therapy Treatment Pl
FDA device recall Z-1102-2026 · posted 2026-01-16 · Open, Classified
Recall details
- Recalling firm
- RAYSEARCH LABORATORIES AB
- Reason for recall
- Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no contours and either have a material override defined, or are of type Bolus, Fixation, or Support. In these cases, adding geometry to the ROI, subsequently modifying geometry, or removing the material override does not invalidate dose as intended.
- Action taken
- RaySearch Laboratories notified consignees via email on about 12/05/2025. Consignees were instructed to follow the outlined steps in the notification letter when adding geometry to an empty ROI with MO or type Bolus, Fixation or Support, educate planning staff and all users about the workaround, inspect units and identify all installed units with the affected software version numbers, and confirm receipt and understanding of the customer notification by responding to the notification email. The issue will be resolved in the next version of RayStation, scheduled for market release in December 2025 (subject to market clearance in some markets). If customers wish to continue using versions of RayStation affected by this notice, all users must maintain awareness of this notice. Alternatively, customers can choose to upgrade to the new version once it becomes available for clinical use. The upgrade to an unaffected software version will be scheduled in coordination with the authorized personnel, considering the specific circumstances and requirements of each individual case. The upgrade may be conducted remotely or onsite, as deemed appropriate.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- MUJ
- Quantity affected
- 0
- Distribution
- Refer to the attached documents: Distribution list 167168 US - updated, Distribution list 167168 OUS
- Date initiated
- 2025-11-28
- Date posted
- 2026-01-16
- Location
- Stockholm, Sweden
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| RayStation 10.1 (K210645) | RaySearch Laboratories AB (PUBL) | 2021-06-29 |