FDA Device recall Z-1412-2019
Leksell GammaPlan 11.1 Product Usage: Leksell GammaPlan is a computer-based system designed for Leksell Gamma Knife treatment planning
- FDA Device
- Class II
- ongoing
- Published 2019-05-29
On 2019-05-29 the FDA classified a Class II recall of Leksell GammaPlan 11.1 Product Usage: Leksell GammaPlan is a computer-based system designed for Leksell Gamma Knife treatment planning by Elekta Instrument Ab, citing the margin tool in Leksell GammaPlan 11.1 systematically overestimates margin in certain areas of the volume.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1412-2019 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2018-06-27 |
| Published | 2019-05-29 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Elekta Instrument Ab |
| Distribution | US |
Product
Leksell GammaPlan 11.1 Product Usage: Leksell GammaPlan is a computer-based system designed for Leksell Gamma Knife treatment planning.
Reason
The margin tool in Leksell GammaPlan 11.1 systematically overestimates margin in certain areas of the volume.
Identifiers
| code_info | Software Version 11.1 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1412-2019%22
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