---
title: "Brand Name: Elekta Medical Linear Accelerator Product Name: Elekta Synergy, E... — FDA record Z-1164-2026 | Is It on Recall"
description: "Due to a manufacturing issue and electrical grounding of systems."
url: https://isitonrecall.com/recall/fda-device-z-1164-2026-brand-name-elekta-medical-linear-accelerator-product-name-elekta-synergy-elekta-harmony-elekta-infin/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# Brand Name: Elekta Medical Linear Accelerator Product Name: Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD... — FDA record Z-1164-2026

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Dec 14, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **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.
- **Classification**: Class II
- **Recalling firm**: Elekta, Inc.
- **Quantity**: 5391
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-1164-2026

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1164-2026%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | 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 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

Worldwide

No US distribution state could be established from this record. Check the official notice.

## Dates in the source

- **Report date**: Feb 4, 2026
- **Recall initiation date**: Dec 14, 2025
- **Center classification date**: Jan 23, 2026

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1164-2026%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Elekta, Inc. records](https://isitonrecall.com/brand/elekta-inc/)