FDA Device recall Z-0079-2017
Radiation Therapy Treatment Planning System, Model 5.0
- FDA Device
- Class II
- terminated
- Published 2016-10-19
On 2016-10-19 the FDA classified a Class II recall of Radiation Therapy Treatment Planning System, Model 5.0 by Raysearch Laboratories Ab, citing 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 trig….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0079-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-05-30 |
| Published | 2016-10-19 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Raysearch Laboratories Ab |
| Distribution | AZ, CA, FL, MT, NC, NY, OH, TX, WA |
Product
Radiation Therapy Treatment Planning System, Model 5.0
Reason
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.
Identifiers
| code_info | 5.0.0.37, 5.0.1.11 and 5.0.2.35 |
|---|
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-0079-2017%22
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