FDA Device recall Z-1110-2026
Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 17.0.0, 17.0.1 Software Version: RayStation v2025, RayStation…
- FDA Device
- Class II
- ongoing
- Published 2026-01-28
On 2026-01-28 the FDA classified a Class II recall of Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 17.0.0, 17.0.1 Software Version: RayStation v2025, RayStation… by Raysearch Laboratories Ab, citing 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 cont….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1110-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-11-28 |
| Published | 2026-01-28 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Raysearch Laboratories Ab |
| Distribution | n/a |
Product
Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 17.0.0, 17.0.1 Software Version: RayStation v2025, RayStation v2025 SP1 Product Description: Radiation Therapy Treatment Planning System Component: No
Reason
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.
Identifiers
| code_info | Lot Code: UDI: 0735000201082220250423, 0735000201094520250702 GTIN: 07350002010822, 07350002010945 Serial Numbers: 17.0…Lot Code: UDI: 0735000201082220250423, 0735000201094520250702 GTIN: 07350002010822, 07350002010945 Serial Numbers: 17.0.0.1270, 17.0.1.113 Software Revision: RayStation v2025, RayStation v2025 SP1 Expiration Date: 2030-10-22 |
|---|
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-1110-2026%22
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