# FDA recall Z-2006-2026

> **Elekta, Inc.** · Class II · device recall initiated 2026-03-19.

## Product

Brand Name: Leksell Vantage Arc System  REF: 1053958

## Reason for recall

Locking mechanisms  may not properly secure to the Arc system, resulting in shifting of coordinates during procedures.

## Distribution

US: AR	AZ	CA	CO	DC	FL	GA	ID	IL	KS	MA	MD	ME	MO	MT	NC	NE	NH	NJ	NM	NV	NY	OH	OK	PA	SC	TX	UT	VA	WA	WI	WV   OUS: Algeria	Australia	Austria	Azerbaijan	Belgium	China	Colombia	Costa Rica	Croatia	Czech Republic	Egypt	Estonia	Finland	France	Germany	Greece	Hong Kong	Hungary	India	Israel	Italy	Japan	Korea, Republic of	Kuwait	Lithuania	Mexico	Morocco	Netherlands	New Zealand	Norway	Pakistan	Panama	Poland	Portugal	Saudi Arabia	Singapore	Slovenia	South Africa	Spain	Sweden	Switzerland	Taiwan	Turkey	United Kingdom

## Key facts

- **Recall number:** Z-2006-2026
- **Recalling firm:** Elekta, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-03-19
- **Report date:** 2026-05-06

- **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-2006-2026

## Citation

> AI Analytics. FDA recall Z-2006-2026. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-2006-2026. Source: US FDA. Licensed CC0.

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