# FDA recall Z-1826-2020

> **Elekta Inc** · Class II · device recall initiated 2020-03-30.

## Product

Leksell Vantage Stereotactic System. Instrument Carrier, Part of Leksell Vantage Arc (1053958). Neurological stereotaxic Instrument

## Reason for recall

A faulty locking piece of the Instrument Carrier that does not fulfil the requirement of locking force to the Arc has been found during an internal check of a Leksell Vantage Stereotactic Arc System.

## Distribution

US nationwide distributions in the states of MA, NH, NC, UT, OH, FL, MN, NY, LA and MT.

## Key facts

- **Recall number:** Z-1826-2020
- **Recalling firm:** Elekta Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-03-30
- **Report date:** 2020-05-06
- **Termination date:** 2024-04-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Saint Charles, MO, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1826-2020

## Citation

> AI Analytics. FDA recall Z-1826-2020. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1826-2020. Source: US FDA. Licensed CC0.

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