FDA Device recall Z-2442-2020
Leksell Vantage Stereotactic System, UDI/GTIN 7340048304887
- FDA Device
- Class II
- terminated
- Published 2020-07-08
On 2020-07-08 the FDA classified a Class II recall of Leksell Vantage Stereotactic System, UDI/GTIN 7340048304887 by Elekta Instrument Ab, citing the locking mechanism at the interface of the Instrument Carrier and the Leksell Vantage Arc may not function properly.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2442-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-06-10 |
| Published | 2020-07-08 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Elekta Instrument Ab |
| Distribution | AZ, FL, IL, LA, MA, MN, MT, NC, NH, NY, OH, TX, UT, WV |
Product
Leksell Vantage Stereotactic System, UDI/GTIN 7340048304887
Reason
The locking mechanism at the interface of the Instrument Carrier and the Leksell Vantage Arc may not function properly.
Identifiers
| code_info | Serial numbers: SH00026, SH00049, SH00061, SH00082, SH00092, SH00111, SH00028, SH00050, SH00072, SH00084, SH00094, SH0…Serial numbers: SH00026, SH00049, SH00061, SH00082, SH00092, SH00111, SH00028, SH00050, SH00072, SH00084, SH00094, SH00118, SH00029, SH00052, SH00073, SH00085, SH00095, SH00121, SH00030, SH00054, SH00074, SH00086, SH00097, SH00123, SH00032, SH00055, SH00077, SH00087, SH00099, SH00127, SH00033, SH00057, SH00078, SH00088, SH00100, SH00162, SH00041, SH00058, SH00079, SH00089, SH00102, SH00044, SH00059, SH00080, SH00090, SH00105, SH00045, SH00060, SH00081, SH00091, SH00108 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2442-2020%22
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