FDA Device recall Z-1339-2026
Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Software Version: 11.1 Product Description: Leksell G…
- FDA Device
- Class II
- ongoing
- Published 2026-02-18
On 2026-02-18 the FDA classified a Class II recall of Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Software Version: 11.1 Product Description: Leksell G… by Elekta, citing due to an error when defining a new stereotactic reference that users fail to first change an already defined obsolete reference to a pre-plan reference. This may result in a trea….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1339-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-12-12 |
| Published | 2026-02-18 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Elekta |
| Distribution | US |
Product
Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Software Version: 11.1 Product Description: Leksell GammaPlan¿ is a computer-based system designed for Leksell Gamma Knife¿ treatment planning.
Reason
Due to an error when defining a new stereotactic reference that users fail to first change an already defined obsolete reference to a pre-plan reference. This may result in a treatment plan that potentially irradiates the incorrect patient location if the error is not detected by users.
Identifiers
| code_info | Lot Code: 07340048311236 (LGP 11.1) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1339-2026%22
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