FDA Device recall Z-0281-2014
Ray Station Radiation Therapy Treatment Planning System, Model Numbers 3.0, 3.5 and 4.0
- FDA Device
- Class II
- terminated
- Published 2013-11-20
On 2013-11-20 the FDA classified a Class II recall of Ray Station Radiation Therapy Treatment Planning System, Model Numbers 3.0, 3.5 and 4.0 by Raysearch Laboratories Ab, citing ray Search Laboratories found an issue with the dose calculation for Elekta motorized wedges in Ray Station 3.0, 3.5 and 4.0. The error presents when a wedge is used for a beam an….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0281-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-10-23 |
| Published | 2013-11-20 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Raysearch Laboratories Ab |
| Distribution | CA, CO, DE, FL, MD, MO, NJ, NY, OH, PA, TN, VA |
Product
Ray Station Radiation Therapy Treatment Planning System, Model Numbers 3.0, 3.5 and 4.0
Reason
Ray Search Laboratories found an issue with the dose calculation for Elekta motorized wedges in Ray Station 3.0, 3.5 and 4.0. The error presents when a wedge is used for a beam and the wedge angle differs from 60 degrees.
Identifiers
| code_info | Software version and build numbers 3.0.0.251, 3.5.0.16, 3.5.1.6, 4.0.0.14, 4.0.1.4. |
|---|
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-0281-2014%22
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