Class II

Medical Device Recall: 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 Componen

Elekta, Inc. · December 14, 2025

Reason for Recall

Due to a manufacturing issue and electrical grounding of systems.

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

Distribution

Worldwide

Quantity Affected

5391

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1164-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.