# FDA recall Z-2442-2020

> **Elekta Instrument AB** · Class II · device recall initiated 2020-06-10.

## Product

Leksell Vantage Stereotactic System, UDI/GTIN 7340048304887

## Reason for recall

The locking mechanism at the interface of the Instrument Carrier and the Leksell Vantage Arc may not function properly.

## Distribution

MA, IL, NH, NC, UT, OH, FL, MN, TX, NY, LA, AZ, MT, WV, Austria, Croatia, Estonia, Finland, France, Germany, Hong Kong, India, Italy, Japan, Kuwait, Lithuania, Netherlands, Norway, Portugal, South Africa, Spain, Sweden, Switzerland, United Kingdom

## Key facts

- **Recall number:** Z-2442-2020
- **Recalling firm:** Elekta Instrument AB
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-06-10
- **Report date:** 2020-07-08
- **Termination date:** 2024-08-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Stockholm, N/A, Sweden

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2442-2020

## Citation

> AI Analytics. FDA recall Z-2442-2020. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-2442-2020. Source: US FDA. Licensed CC0.

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