Elekta Instrument AB Kungstensgatan 18 Stockholm Sweden Leksell Vantage Stereotactic System, UDI/GTIN 7340048304887 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Leksell Vantage Stereotactic System, UDI/GTIN 7340048304887
Brand
Elekta Instrument AB Kungstensgatan 18 Stockholm Sweden
Lot Codes / Batch Numbers
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
Products Sold
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
Elekta Instrument AB Kungstensgatan 18 Stockholm Sweden is recalling Leksell Vantage Stereotactic System, UDI/GTIN 7340048304887 due to The locking mechanism at the interface of the Instrument Carrier and the Leksell Vantage Arc may not function properly.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The locking mechanism at the interface of the Instrument Carrier and the Leksell Vantage Arc may not function properly.
Recommended Action
Per FDA guidance
The firm notified their consignees on 06/10/2020 by email. The notice explained the problem and provided directions on the removal of the spring. The firm offered assistance with the removal and provided the following contact: Neurosupport@elekta.com.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, FL, IL, LA, MA, MN, MT, NH, NY, NC, OH, TX, UT, WV
Page updated: Jan 10, 2026