Leksell Vantage Stereotactic System — Class II medical device recall Z-1826-2020
Terminated recall by Elekta Inc, reported 2020-05-06, distributed nationwide. A faulty locking piece of the Instrument Carrier that does not fulfil the requirement of locking force to the
| Recall number | Z-1826-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Elekta Inc, Saint Charles, MO, United States |
| Recall initiated | 2020-03-30 |
| Classified | 2020-04-29 |
| Reported by FDA | 2020-05-06 |
| Terminated | 2024-04-10 |
| Distributed | Nationwide (US) |
| Quantity | 25 units |
| UPC / GTIN / UDI-DI | 07340048304887 |
| Serial numbers | SH00106, SH00110, SH00111, SH00112, SH00114, SH00120, SH00143, SH00144, SH00147, SH00148, SH00149, SH00150, SH00157, SH00158, SH00159, SH00160, SH00161, SH00162, SH00163, SH00164, SH00165, SH00166, SH00167, SH00168, SH00178 |
Product
Leksell Vantage Stereotactic System. Instrument Carrier, Part of Leksell Vantage Arc (1053958). Neurological stereotaxic Instrument
Reason for recall
A faulty locking piece of the Instrument Carrier that does not fulfil the requirement of locking force to the Arc has been found during an internal check of a Leksell Vantage Stereotactic Arc System.
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-1826-2020. 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.