FDA Device recall Z-1310-2015
RayStation Radiation Therapy Treatment Planning System
- FDA Device
- Class II
- terminated
- Published 2015-04-01
On 2015-04-01 the FDA classified a Class II recall of RayStation Radiation Therapy Treatment Planning System by Raysearch Laboratories Ab, citing an issue with photon dose calculation for DMLC (Dynamic MLC) plans for machines where the MLC is positioned above the jaws, e.g. some Elekta linacs. The magnitude of the error dep….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1310-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-03-04 |
| Published | 2015-04-01 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Raysearch Laboratories Ab |
| Distribution | US |
Product
RayStation Radiation Therapy Treatment Planning System; -- RayStation 3.5, RayStation 4.0, RayStation 4.5 and RayStation 4.7. For RayStation 4.7, the issue applies also to machines with fixed jaws, regardless of MLC/jaw position. RayStation is a software system designed for treatment planning and analysis of radiation therapy.
Reason
An issue with photon dose calculation for DMLC (Dynamic MLC) plans for machines where the MLC is positioned above the jaws, e.g. some Elekta linacs. The magnitude of the error depends on the beam model output factor corrections and on the individual DMLC plan characteristics.
Identifiers
| code_info | Build numbers 3.5.0.16, 3.5.1.6, 4.0.0.14, 4.0.1.4, 4.0.2.9, 4.0.3.4, 4.5.0.19, 4.5.1.14 and 4.7.0.15 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1310-2015%22
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