FDA Device recall Z-0433-2026
Brand Name: Leksell Stereotactic System Product Name: Leksell Vantage Stereotactic System Software Version: n/a Product Description: The In…
- FDA Device
- Class II
- ongoing
- Published 2025-11-12
On 2025-11-12 the FDA classified a Class II recall of Brand Name: Leksell Stereotactic System Product Name: Leksell Vantage Stereotactic System Software Version: n/a Product Description: The In… by Elekta, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0433-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-09-30 |
| Published | 2025-11-12 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Elekta |
| Distribution | US |
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
Identifiers
| code_info | Lot Code: UDI References: Arc: 07340048304856 Support Arc: 07340048304849 Arcs and Support Arcs with Serial Numbers: SH00001-SH00338 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0433-2026%22
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