Radiation Therapy Treatment Planning System — Class II medical device recall Z-0079-2017
Terminated recall by RAYSEARCH LABORATORIES AB, reported 2016-10-19, distributed in AZ, CA, FL, MT, NC, NY, OH, TX…. For a treatment plan consisting of multiple beam sets, the table for ROI plan dose statistics in the report ma
| Recall number | Z-0079-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | RAYSEARCH LABORATORIES AB, Stockholm, N/A, Sweden |
| Recall initiated | 2016-05-30 |
| Classified | 2016-10-13 |
| Reported by FDA | 2016-10-19 |
| Terminated | 2017-09-22 |
| Distributed | AZ, CA, FL, MT, NC, NY, OH, TX, WA |
| Model numbers | 5.0 |
Product
Radiation Therapy Treatment Planning System, Model 5.0
Reason for recall
For a treatment plan consisting of multiple beam sets, the table for ROI plan dose statistics in the report may show the statistics for a beam set dose. The error can only be triggered when using a report template where statistics for a beam set dose is included as the last dose statistics prior to the plan dose statistics.
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-0079-2017. 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.