Leksell GammaPlan 11 — Class II medical device recall Z-1412-2019
Ongoing recall by Elekta Instrument AB, reported 2019-05-29, distributed nationwide. The margin tool in Leksell GammaPlan 11.1 systematically overestimates margin in certain areas of the volume.
| Recall number | Z-1412-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Elekta Instrument AB, Stockholm, N/A, Sweden |
| Recall initiated | 2018-06-27 |
| Classified | 2019-05-23 |
| Reported by FDA | 2019-05-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, DE, ES, FR, GB, HK, IT, JP, KR, NL, RO, TR |
| Quantity | 52 devices |
Product
Leksell GammaPlan 11.1 Product Usage: Leksell GammaPlan is a computer-based system designed for Leksell Gamma Knife treatment planning.
Reason for recall
The margin tool in Leksell GammaPlan 11.1 systematically overestimates margin in certain areas of the volume.
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-1412-2019. 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.