FDA Device recall Z-1712-2016
RayStation Therapy Treatment Planning System Stand-alone Software 3.0, 3.5, 4.0, 4.5 and 4.7., designed for treatment planning and analysis…
- FDA Device
- Class II
- terminated
- Published 2016-06-01
On 2016-06-01 the FDA classified a Class II recall of RayStation Therapy Treatment Planning System Stand-alone Software 3.0, 3.5, 4.0, 4.5 and 4.7., designed for treatment planning and analysis… by Raysearch Laboratories Ab, citing A software issue with editing tools that use the left mouse button held down, for drawing in and interacting with the patient views and beams eye views. The views can become unsyn….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1712-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-02-10 |
| Published | 2016-06-01 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Raysearch Laboratories Ab |
| Distribution | AR, AZ, CA, CO, CT, DE, FL, GA, IL, LA, MA, MD, MI, MS, NC, NJ, NV, NY, OH, OR, PA, RI, TN, WA |
Product
RayStation Therapy Treatment Planning System Stand-alone Software 3.0, 3.5, 4.0, 4.5 and 4.7., designed for treatment planning and analysis of radiation therapy.
Reason
A software issue with editing tools that use the left mouse button held down, for drawing in and interacting with the patient views and beams eye views. The views can become unsynchronized with the stored data if simultaneously right clicking, pressing Ctrl-S or Ctrl-Z while the left mouse button is held down. This bug does not affect dose computations, which are based on the stored system state.
Identifiers
| code_info | 3.0.0.251 , 3.5.0.16 , 3.5.1.6 , 4.0.0.14 , 4.0.1.4 , 4.0.2.9 , 4.0.3.4 , 4.5.0.19 , 4.5.1.14 , 4.5.2.7 , 4.7…3.0.0.251 , 3.5.0.16 , 3.5.1.6 , 4.0.0.14 , 4.0.1.4 , 4.0.2.9 , 4.0.3.4 , 4.5.0.19 , 4.5.1.14 , 4.5.2.7 , 4.7.0.15 , 4.7.1.10 , 4.7.2.5 , 4.7.3.13 or 4.7.4.4 |
|---|
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-1712-2016%22
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