FDA recall Z-2006-2026

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

Status

Ongoing

Initiation date

2026-03-19

Report date

2026-05-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Atlanta, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2006-2026