Recall Z-0433-2026 ยท HAW Neurological Stereotaxic Instrument
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 i
| Date | Nov 5, 2025 (initiated Sep 30, 2025) |
| Status | Open, Classified |
| 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 i |
| 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, Fr |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K190887 | Leksell Vantage Stereotactic System Elekta Instrument AB, Aug 1, 2019 |