Class II Recall

Brand Name: Leksell Stereotactic System Product Name: Leksell Vantage Stereotactic System Software Version: n/a Produ

Summary

The FDA issued a Class II for Brand Name: Leksell Stereotactic System Product Name: Leksell Vantage Stereotac by Elekta, Inc.. 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.

Details

Source

Device Recall

External ID

Z-0433-2026

Action Date

2025-11-12

Status

Ongoing

Product Description

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.

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

Quantity Affected: 338

Reason for Recall

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

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.

Type: Voluntary: Firm initiated

Recall Initiated: 2025-09-30

Company

Elekta, Inc.

Atlanta, GA

Context & Analysis

This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.

This was one of 185 device recalls issued in the same week, part of 413 device-related FDA actions this month.

Elekta, Inc. has 24 FDA actions in our database, including 24 recalls.

Frequently Asked Questions

What is a Class II recall?

A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.

What should I do if I have this product?

Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Elekta, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does Elekta, Inc. have FDA actions?

Elekta, Inc. has 24 FDA actions in our database, including 24 recalls and 0 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "Z-0433-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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