FDA Device recall Z-1468-2020
RayStation/RayPlan 9B, Build Number 9.1.0.933, stand-alone software treatment planning system
- FDA Device
- Class II
- terminated
- Published 2020-03-18
On 2020-03-18 the FDA classified a Class II recall of RayStation/RayPlan 9B, Build Number 9.1.0.933, stand-alone software treatment planning system by Raysearch Laboratories Ab, citing there is a potential for erroneous propagation of the current tabletop positions when applying pitch or roll correction. Even though pitch and roll correction is never propagated,….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1468-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-02-20 |
| Published | 2020-03-18 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Raysearch Laboratories Ab |
| Distribution | TN |
Product
RayStation/RayPlan 9B, Build Number 9.1.0.933, stand-alone software treatment planning system
Reason
There is a potential for erroneous propagation of the current tabletop positions when applying pitch or roll correction. Even though pitch and roll correction is never propagated, non-zero pitch or roll causes the lateral, longitudinal and vertical values propagated to be incorrect.
Identifiers
| code_info | UDI 07350002010266 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1468-2020%22
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