Leksell Vantage Stereotactic System recallZ-0433-2026 · Elekta, Inc. · initiated Sep 30, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Elekta, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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
FDA root cause category: Process change control
What the company is doing
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.
Recall details
- Recall number
- Z-0433-2026
- Status
- Open, Classified
- Initiated by the company
- Sep 30, 2025
- Posted by the FDA
- Nov 5, 2025
- Recalling firm
- Elekta, Inc.
- Quantity
- 338
- Product code
- HAW
- FDA submissions
- K190887
- 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.
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.
Code information (models, lots, serial numbers)
Lot Code: UDI References: Arc: 07340048304856 Support Arc: 07340048304849 Arcs and Support Arcs with Serial Numbers: SH00001-SH00338
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- Leksell Vantage Stereotactic System 1054958Elekta Instrument AB · Neurological stereotaxic Instrument2 recalls0 reports
- Leksell Vantage Stereotactic System 1054956Elekta Instrument AB · Neurological stereotaxic Instrument1 recall8 reports
Product lines
Other devices under the same FDA submission
1 device cleared under K190887 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Leksell Vantage Stereotactic System 1072447Elekta Instrument AB · Neurological Stereotaxic Instrument2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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