Recall Z-1164-2026— Elekta, Inc.

Name: FDA recall Z-1164-2026
Creator: U.S. Food and Drug Administration
Published: 2025-12-14

Class II · Ongoing

Class II FDA medical device recall by Elekta, Inc., initiated 2025-12-14. It names one FDA 510(k) clearance: K210500. 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..

Recalling firm: Elekta, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2025-12-14
Firm location: Atlanta, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K210500 — Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HDElekta Limited·cleared 2021-06-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.