FDA Device recall Z-2574-2014
FOCAL Sim Workstation, Radiation Treatment Planning System
- FDA Device
- Class II
- terminated
- Published 2014-09-10
On 2014-09-10 the FDA classified a Class II recall of FOCAL Sim Workstation, Radiation Treatment Planning System by Elekta, citing when DICOM is exporting an arc plan (VMAT, Dynamic Conformal of 3D Static Arcs) and using the Composite Field Sequencing (CFS) feature, the DICOM exported plan will not match the….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2574-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-08-18 |
| Published | 2014-09-10 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Elekta |
| Distribution | US |
Product
FOCAL Sim Workstation, Radiation Treatment Planning System. Used for patient contouring and viewing of treatment plan outputs. Also able to perform CT simulations and forward their information to the RTP System for dose calculation.
Reason
When DICOM is exporting an arc plan (VMAT, Dynamic Conformal of 3D Static Arcs) and using the Composite Field Sequencing (CFS) feature, the DICOM exported plan will not match the approved treatment plan.
Identifiers
| code_info | Software versions 4.70.00 & 4.80.00 |
|---|
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-2574-2014%22
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