Device 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

Z-1164-2026

December 14, 2025

Class II

Product summary

Firm: Elekta, Inc.
Event: Event 97958
Status: Ongoing
Classification: Class II
Quantity: 5391
Official record key: device-enforcement:Z-1164-2026

Official wording

Reason: Due to a manufacturing issue and electrical grounding of systems.

Code information: 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

Distribution pattern: Worldwide

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Due to a manufacturing issue and electrical grounding of systems.