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Open, Classified

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.

FDA Recall Z-0433-2026 · Posted 2025-11-05

Recalling FirmElekta, Inc.
Recall StatusOpen, Classified
Product CodeHAW
Date Initiated2025-09-30
Product Quantity338

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

Firm 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.

Root Cause

Process change control

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K190887Leksell Vantage Stereotactic SystemElekta Instrument AB · 2019-08-01

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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