Recall Z-0433-2026— Elekta, Inc.
Class II · Ongoing
Class II FDA medical device recall by Elekta, Inc., initiated 2025-09-30. It names one FDA 510(k) clearance: K190887. 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.. 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.
- Recalling firm
- Elekta, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-09-30
- Firm location
- Atlanta, GA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.