Brand Name: Leksell Stereotactic System Product Name: Leksell Vantage… — Class II medical device recall Z-0433-2026
Ongoing recall by Elekta, Inc., reported 2025-11-12, distributed nationwide. Due to increased risk that paint flakes from the engravings may separate from the device and there is the poss
| Recall number | Z-0433-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Elekta, Inc., Atlanta, GA, United States |
| Recall initiated | 2025-09-30 |
| Classified | 2025-11-05 |
| Reported by FDA | 2025-11-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, CH, CN, CO, CR, CZ, DE, DZ, EE, ES, FI, FR, GB, GR, HK, HR, HU, IL, IN, IT, JP, KR, KW, LT, MX, NL, NO, NZ, PK, PT, SA, SE, SG, TR, TW, ZA |
| Quantity | 338 |
| UPC / GTIN / UDI-DI | 07340048304849, 07340048304856 |
| Serial numbers | SH00001-SH00338 |
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 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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0433-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.