FDA recall Z-1164-2026

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 for recall

Due to a manufacturing issue and electrical grounding of systems.

Distribution

Worldwide

Key facts

Status

Ongoing

Initiation date

2025-12-14

Report date

2026-02-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Atlanta, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1164-2026