Class II

Medical Device Recall: Brand Name: Leksell Vantage Arc System REF: 1053958

Elekta, Inc. · March 19, 2026

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

States Affected

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

Quantity Affected

768 (364Left/364Right)

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2006-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.