FDA Device recall Z-2785-2015
Radiation Therapy Treatment Planning System software RayStation is a software system designed for treatment planning and analysis of radiat…
- FDA Device
- Class II
- terminated
- Published 2015-09-23
On 2015-09-23 the FDA classified a Class II recall of Radiation Therapy Treatment Planning System software RayStation is a software system designed for treatment planning and analysis of radiat… by Raysearch Laboratories Ab, citing an error caused by a floating point precision problem tends to cause a problem with the display of isodose lines for dose and dose difference and color tables for dose, dose diffe….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2785-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-05-29 |
| Published | 2015-09-23 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Raysearch Laboratories Ab |
| Distribution | US |
Product
Radiation Therapy Treatment Planning System software RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user.
Reason
An error caused by a floating point precision problem tends to cause a problem with the display of isodose lines for dose and dose difference and color tables for dose, dose difference and PET images
Identifiers
| code_info | software build numbers are 4.7.0.15 or 4.7.1.10 |
|---|
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-2785-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.