Brand Name: Elekta Medical Linear Accelerator Product Name: Elekta… — Class II medical device recall Z-1164-2026
Ongoing recall by Elekta, Inc., reported 2026-02-04. Due to a manufacturing issue and electrical grounding of systems.
| Recall number | Z-1164-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Elekta, Inc., Atlanta, GA, United States |
| Recall initiated | 2025-12-14 |
| Classified | 2026-01-23 |
| Reported by FDA | 2026-02-04 |
| Quantity | 5,391 |
| UPC / GTIN / UDI-DI | 05060191071505, 05060191071512, 05060191071529, 05060191071543, 05060191071550, 05060191071574, 05060191071581, 05060191071604, 07340201503461 |
Product
Brand Name: Elekta Medical Linear Accelerator Product Name: Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD Software Version: N/A Product Description: Digital Linear Accelerator Component: No
Reason for recall
Due to a manufacturing issue and electrical grounding of systems.
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-1164-2026. 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.