Class IIReported 2026-02-04

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

Recalled by Elekta, Inc.

Reason for Recall

Due to a manufacturing issue and electrical grounding of systems.

Recall Number

Z-1164-2026

Classification

Class II

Status

Ongoing

Category

device

Initiated

2025-12-14

Reported

2026-02-04

Distribution

Worldwide

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

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.