RayStation Therapy Treatment Planning System Stand-alone Software 3 — Class II medical device recall Z-1712-2016
Terminated recall by RAYSEARCH LABORATORIES AB, reported 2016-06-01, distributed in AR, AZ, CA, CO, CT, DE, FL, GA…. A software issue with editing tools that use the left mouse button held down, for drawing in and interacting w
| Recall number | Z-1712-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | RAYSEARCH LABORATORIES AB, Stockholm, N/A, Sweden |
| Recall initiated | 2016-02-10 |
| Classified | 2016-05-24 |
| Reported by FDA | 2016-06-01 |
| Terminated | 2017-04-24 |
| Distributed | AR, AZ, CA, CO, CT, DE, FL, GA, IL, LA, MA, MD, MI, MS, NC, NJ, NV, NY, OH, OR, PA, RI, TN, WA |
| Countries outside the US | AT, AU, BE, CA, CH, CN, DE, DZ, ES, FR, GB, IR, IT, JP, KR, NL, NO, NZ, SE, TH |
| Reason classes | software |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1712-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.