Leksell Vantage Stereotactic System — Class II medical device recall Z-2442-2020
Terminated recall by Elekta Instrument AB, reported 2020-07-08, distributed in AZ, FL, IL, LA, MA, MN, MT, NC…. The locking mechanism at the interface of the Instrument Carrier and the Leksell Vantage Arc may not function
| Recall number | Z-2442-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Elekta Instrument AB, Stockholm, N/A, Sweden |
| Recall initiated | 2020-06-10 |
| Classified | 2020-06-26 |
| Reported by FDA | 2020-07-08 |
| Terminated | 2024-08-27 |
| Distributed | AZ, FL, IL, LA, MA, MN, MT, NC, NH, NY, OH, TX, UT, WV |
| Countries outside the US | AT, CH, DE, EE, ES, FI, FR, GB, HK, HR, IN, IT, JP, KW, LT, NL, NO, PT, SE, ZA |
| Quantity | 51 devices |
| UPC / GTIN / UDI-DI | 07340048304887 |
| Serial numbers | SH00026, SH00028, SH00029, SH00030, SH00032, SH00033, SH00041, SH00044, SH00045, SH00049, SH00050, SH00052, SH00054, SH00055, SH00057, SH00058, SH00059, SH00060, SH00061, SH00072, SH00073, SH00074, SH00077, SH00078, SH00079 and 26 more |
Product
Leksell Vantage Stereotactic System, UDI/GTIN 7340048304887
Reason for recall
The locking mechanism at the interface of the Instrument Carrier and the Leksell Vantage Arc may not function properly.
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-2442-2020. 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.