Laksell GammaPlan — Class II medical device recall Z-1719-2015
Terminated recall by Elekta, Inc., reported 2015-06-17, distributed nationwide. Memory can become corrupted when creating a fused study via drag and drop in Leksell GammaPlan 10.2.
| Recall number | Z-1719-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Elekta, Inc., Atlanta, GA, United States |
| Recall initiated | 2015-06-01 |
| Classified | 2015-06-05 |
| Reported by FDA | 2015-06-17 |
| Terminated | 2016-01-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | DE, GB, JP |
| Quantity | 10 |
Product
Laksell GammaPlan, a computer based dose planning system specifically designed for use with Leksell Gamma Knife, radiation therapy treatment.
Reason for recall
Memory can become corrupted when creating a fused study via drag and drop in Leksell GammaPlan 10.2.
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-1719-2015. 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.