FDA Device recall Z-1244-2015
Focal Sim radiation therapy treatment planning system
- FDA Device
- Class II
- terminated
- Published 2015-03-11
On 2015-03-11 the FDA classified a Class II recall of Focal Sim radiation therapy treatment planning system by Elekta, citing incorrect CT to ED when using the Monaco Image Statistics Tool.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1244-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-12-19 |
| Published | 2015-03-11 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Elekta |
| Distribution | US |
Product
Focal Sim radiation therapy treatment planning system
Reason
Incorrect CT to ED when using the Monaco Image Statistics Tool.
Identifiers
| code_info | Focal Release 4.80 |
|---|
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-1244-2015%22
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