FDA Device recall Z-1186-2025
Brand Name: RayStation -Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 8.1.0.47, 8.1.1.8, 8.1.2.5, 9.0.0.1…
- FDA Device
- Class II
- ongoing
- Published 2025-02-26
On 2025-02-26 the FDA classified a Class II recall of Brand Name: RayStation -Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 8.1.0.47, 8.1.1.8, 8.1.2.5, 9.0.0.1… by Raysearch Laboratories Ab, citing inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and light ion treatment pl….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1186-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-01-16 |
| Published | 2025-02-26 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Raysearch Laboratories Ab |
| Distribution | US |
Product
Brand Name: RayStation -Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 8.1.0.47, 8.1.1.8, 8.1.2.5, 9.0.0.113 and 9.0.1.142 Software Version: RayStation 8B, 8B Service Pack 1 and 2, 9A and 9A Service Pack 1
Reason
Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and light ion treatment plans when a HU-to-mass density CT calibration curve used in RayStation version 4.5 to 2024B including some service packs.
Identifiers
| code_info | Lot Code: UDI: 0735000201011220180608, 0735000201013620180928, 0735000201017420190612 and 0735000201048820220420 GTIN:…Lot Code: UDI: 0735000201011220180608, 0735000201013620180928, 0735000201017420190612 and 0735000201048820220420 GTIN: 07350002010112, 07350002010136, 07350002010174 and 07350002010488 Serial Numbers: 8.0.0.61, 8.0.1.10, 9.0.0.113 and 9.0.1.142 Software Revisions: RayStation 8B, 8B Service Pack 1 and 2, 9A and 9A Service Pack 1 Expiration Date: 2027-12-15 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1186-2025%22
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