FDA Device recall Z-1419-2013
RayStation Therapy Treatment Planning System, Model Numbers 2.0, 2.5, and 3.0
- FDA Device
- Class II
- terminated
- Published 2013-06-05
On 2013-06-05 the FDA classified a Class II recall of RayStation Therapy Treatment Planning System, Model Numbers 2.0, 2.5, and 3.0 by Raysearch Laboratories Ab, citing under some circumstances, imported CT, MR and PET images are offset from their true positions by one pixel in one or two directions. Users must be aware of this information to avo….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1419-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-02-15 |
| Published | 2013-06-05 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Raysearch Laboratories Ab |
| Distribution | CT, FL, MA, MO, NY, OH |
Product
RayStation Therapy Treatment Planning System, Model Numbers 2.0, 2.5, and 3.0; CLASSIFICATION NAME: System, Planning, Radiation Therapy Treatment. RayStation is a software system designed for treatment planning and analysis of radiation therapy.
Reason
Under some circumstances, imported CT, MR and PET images are offset from their true positions by one pixel in one or two directions. Users must be aware of this information to avoid incorrect dose calculations during treatment planning.
Identifiers
| code_info | Software version and build numbers 2.0.0.15, 2.5.1.89, and 3.0.0.251 (to determine if the version used is affected, bri…Software version and build numbers 2.0.0.15, 2.5.1.89, and 3.0.0.251 (to determine if the version used is affected, bring up the About box in the RayStation application and check the build number reported0. |
|---|
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-1419-2013%22
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