FDA Device recall Z-1307-2014
RayStation Radiation Therapy Treatment Planning System, models 2.5, 3.0, 3.5 and 4.0
- FDA Device
- Class II
- terminated
- Published 2014-04-09
On 2014-04-09 the FDA classified a Class II recall of RayStation Radiation Therapy Treatment Planning System, models 2.5, 3.0, 3.5 and 4.0 by Raysearch Laboratories Ab, citing potential for dose errors due to software program errors.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1307-2014 |
| 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 | AZ, CA, CO, CT, DE, FL, IL, MD, MS, NJ, NY, OH, PA, TN, WA |
Product
RayStation Radiation Therapy Treatment Planning System, models 2.5, 3.0, 3.5 and 4.0; a software system designed for treatment planning and analysis of radiation therapy.
Reason
Potential for dose errors due to software program errors.
Identifiers
| code_info | MODEL #(s): 2.5, 3.0, 3.5 and 4.0; VERSIONS: 2.5.1.89, 3.0.0.251, 3.5.0.16, 3.5.1.6, 4.0.0.14, 4.0.1.4, 4.0.2.9 |
|---|
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-1307-2014%22
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