FDA Device recall Z-2206-2016
RayStation 3.0, RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7 and RayStation 5 --- Radiation Therapy Treatment Planning Sy…
- FDA Device
- Class II
- terminated
- Published 2016-07-27
On 2016-07-27 the FDA classified a Class II recall of RayStation 3.0, RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7 and RayStation 5 --- Radiation Therapy Treatment Planning Sy… by Raysearch Laboratories Ab, citing an issue was found with the evaluation of biological clinical goals in RayStation 3.0, RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7 and RayStation 5. Biological….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2206-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-07-01 |
| Published | 2016-07-27 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Raysearch Laboratories Ab |
| Distribution | CA, CT, DE, FL, HI, ME, MO, NY, OH, TX, WA |
Product
RayStation 3.0, RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7 and RayStation 5 --- Radiation Therapy Treatment Planning System --- designed for treatment planning and analysis of radiation therapy, provides treatment unit set up parameters and estimates dose distributions.
Reason
An issue was found with the evaluation of biological clinical goals in RayStation 3.0, RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7 and RayStation 5. Biological clinical goals for an adapted plan based on another planning CT than the original planning CT will show incorrect values. -- To the best of the firm's knowledge, the issue has not caused any patient mistreatment or other incidents. However, the user must be aware of the following information to avoid incorrect plan evaluation during treatment planning.
Identifiers
| code_info | Software build numbers: 3.0.0.251, 3.5.0.16, 3.5.1.6, 4.0.0.14, 4.0.1.4, 4.0.2.9, 4.0.3.42, 4.5.0.19, 4.5.1.14, 4.5.2.7…Software build numbers: 3.0.0.251, 3.5.0.16, 3.5.1.6, 4.0.0.14, 4.0.1.4, 4.0.2.9, 4.0.3.42, 4.5.0.19, 4.5.1.14, 4.5.2.7, 4.7.0.15, 4.7.1.10, 4.7.2.5, 4.7.4.4, 4.7.5.4, 5.0.0.37, 5.0.1.11 and 5.0.2.35 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2206-2016%22
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