Elekta, Inc.: 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.

Recall number

Z-0433-2026

Recalling firm

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.

Status

Open, Classified

Initiated

2025-09-30

Posted

2025-11-05

Terminated

not on file

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

Root cause

Process change control

Action

On 09/30/2025, the firm sent via email an "URGENT MEDICAL DEVICE CORRECTION" Letter informing customers that specified serial numbers, there is an increased risk that paint flakes from the engravings may separate from the Leksell Vantage Arc System components. Separation of paint flakes is likely to occur during cleaning and sterilization. If paint flakes are not washed away during the cleaning and sterilization process, these could remain on the Leksell Vantage Arc System when used in surgery. This poses a risk of paint flakes entering the surgical area. This situation has not been observed in clinical practice, but the risk should be fully considered and mitigated.

Quantity

338

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.

Lot, serial or model codes

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

510(k) numbers

["K190887"]

PMA numbers

not on file

Product code

HAW

Firm FEI

1037831

Firm city

Atlanta

Firm state

GA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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