FDA Device recall Z-1193-2025
Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 6.0.0.24 Software Version: RayStati…
- 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: 6.0.0.24 Software Version: RayStati… 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-1193-2025 |
| 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: 6.0.0.24 Software Version: RayStation 6
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: 00735000201001320161214 GTIN: 07350002010013 Serial Numbers: 6.0.0.24 Software Revisions: RayStation 6 Expiration Date: 2021-12-22 |
|---|
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-1193-2025%22
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