Elekta, Inc. recalls Brand Name: Elekta Medical Linear Accelerator Product Name: Elekta Synergy
- Recalling company
- Elekta, Inc.
- 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
- Due to a manufacturing issue and electrical grounding of systems.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Dec 14, 2025
- Reported
- Feb 4, 2026
- Distribution
- Worldwide
- Status
- Ongoing
- Quantity
- 5391
- Lot / codes
- Lot Code: 05060191071550 (NFB) Elekta Synergy 05060191071505 (FB) 05060191071543 (NFB) Elekta Infinity 05060191071512 (FB) 05060191071574 (NFB) Versa HD 05060191071529 (FB) 05060191071581 Harmony 05060191071604 Harmony Pro 07340201503461 Elekta Evo
- Company location
- Atlanta, GA
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-1164-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-1164-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.