⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

Elekta, Inc.: Brand Name: Elekta Medical Linear Accelerator Product Name: Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD Software Version: N/

Medical DevicesSource: FDA (device) · Date: 2026-02-04

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
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 / hazard
Due to a manufacturing issue and electrical grounding of systems.
Classification
Class II
Status
Ongoing
Distribution / sold at
Worldwide
Recall initiated
2025-12-14
Code info
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
Product quantity
5391
Voluntary mandated
Voluntary: Firm initiated
City
Atlanta
State
GA
Country
United States
Event id
97958
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