Elekta Instrument AB: Medical Device Recall in 2020 - (Recall #: Z-2442-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

Leksell Vantage Stereotactic System, UDI/GTIN 7340048304887

Product Classification:

Class II

Date Initiated: June 10, 2020

Date Posted: July 8, 2020

Recall Number: Z-2442-2020

Event ID: 85836

Reason for Recall:

The locking mechanism at the interface of the Instrument Carrier and the Leksell Vantage Arc may not function properly.

Status: Terminated

Product Quantity: 51 devices

Code Information:

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

Distribution Pattern:

MA, IL, NH, NC, UT, OH, FL, MN, TX, NY, LA, AZ, MT, WV, Austria, Croatia, Estonia, Finland, France, Germany, Hong Kong, India, Italy, Japan, Kuwait, Lithuania, Netherlands, Norway, Portugal, South Africa, Spain, Sweden, Switzerland, United Kingdom

Voluntary or Mandated:

Voluntary: Firm initiated