FDA Device recall Z-1308-2014
RaySearch Ray Station, Radiation Therapy Treatment Planning System, Stand-alone software
- FDA Device
- Class II
- terminated
- Published 2014-04-09
On 2014-04-09 the FDA classified a Class II recall of RaySearch Ray Station, Radiation Therapy Treatment Planning System, Stand-alone software by Raysearch Laboratories Ab, citing raySearch Laboratories has recalled RaySearch Ray Station 4.0 software due to clinical dose calculation errors during radiation therapy.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1308-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-02-06 |
| Published | 2014-04-09 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Raysearch Laboratories Ab |
| Distribution | FL, IL, MA, MD, NJ, OH, WA |
Product
RaySearch Ray Station, Radiation Therapy Treatment Planning System, Stand-alone software
Reason
RaySearch Laboratories has recalled RaySearch Ray Station 4.0 software due to clinical dose calculation errors during radiation therapy.
Identifiers
| code_info | Model#: 4.30; Version: 4.0.2.9; 3D-CRT optimization or Fallback Planning Licenses |
|---|
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-1308-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.