Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment… — Class II medical device recall Z-1340-2026
Ongoing recall by Elekta, Inc., reported 2026-02-18, distributed nationwide. Due to an error when defining a new stereotactic reference that users fail to first change an already defined
| Recall number | Z-1340-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Elekta, Inc., Atlanta, GA, United States |
| Recall initiated | 2025-12-12 |
| Classified | 2026-02-10 |
| Reported by FDA | 2026-02-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AU, BE, BG, BR, CA, CN, CO, CZ, DE, DO, DZ, EC, EG, ES, FR, GB, HK, HR, IN, IQ, IR, IT, JO, JP, KR, KW, LT, MA, MX, MY, NL, NO, PE, PK, PL, RO, SA, SE, SV, TH, TR, TW, VN, ZA |
| UPC / GTIN / UDI-DI | 07340048311878, 07340201502136 |
Product
Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Software Version: 11,3, 11.4 Product Description: Leksell GammaPlan¿ is a computer-based system designed for Leksell Gamma Knife¿ treatment planning.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1340-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.