Elekta, Inc. recalls Brand Name: Leksell Stereotactic System Product Name: Leksell Vantage Stereotactic System

Recalling company

Elekta, Inc.

Product

Brand Name: Leksell Stereotactic System Product Name: Leksell Vantage Stereotactic System Software Version: n/a Product Description: The Intended Purpose of Leksell¿ Vantage" Stereotactic System is target localization and fixation of the patient head in a coordinate system in order to perform stereotactic neurosurgical procedures, for example; deep brain stimulation, lesioning, biopsies, targeted injections, aspirations and minimal invasive tumor treatments.

Reason

Due to increased risk that paint flakes from the engravings may separate from the device and there is the possibility that the flake may inadvertently enter the wound

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

Sep 30, 2025

Reported

Nov 12, 2025

Distribution

Worldwide - U.S. Nationwide distribution in the states of AR, CA, CO, FL, ID, IL, LA, MA, MI, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, PA, SC, TN, TX, UT, WA, WI, and WV. The countries of Algeria, Australia, Austria, Belgium, China, Colombia, Costa Rica, Croatia, Czech Republic, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Republic of Korea, Kuwait, Lithuania, Mexico, Netherlands, New Zealand, Norway, Pakistan, Portugal, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, and United Kingdom.

Status

Ongoing

Quantity

338

Lot / codes

Lot Code: UDI References: Arc: 07340048304856 Support Arc: 07340048304849 Arcs and Support Arcs with Serial Numbers: SH00001-SH00338

Company location

Atlanta, GA

Recall type

Voluntary: Firm initiated

Recall number

Z-0433-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-0433-2026 in the FDA Enforcement Report. Also see FDA recall press releases.