# FDA recall Z-1164-2026

> **Elekta, Inc.** · Class II · device recall initiated 2025-12-14.

## 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

- **Recall number:** Z-1164-2026
- **Recalling firm:** Elekta, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-12-14
- **Report date:** 2026-02-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Atlanta, GA, United States

## Primary source

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

## Citation

> AI Analytics. FDA recall Z-1164-2026. Retrieved 2026-08-18 from https://api.ai-analytics.org/recall/Z-1164-2026. Source: US FDA. Licensed CC0.

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