Elekta Instrument AB

FDA Regulatory Profile

Summary

Total Recalls
5 (2 Class I)
510(k) Clearances
35
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0227-2025Class IElekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, Diameter / 14 GaugSeptember 25, 2024
Z-1397-2024Class IElekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, 2.1mm Diameter / 14March 15, 2024
Z-1309-2023Class IIInstructions for Use for the following Leksell Stereotactic System and Leksell Neurosurgical InstrumMarch 1, 2023
Z-2442-2020Class IILeksell Vantage Stereotactic System, UDI/GTIN 7340048304887June 10, 2020
Z-1412-2019Class IILeksell GammaPlan 11.1 Product Usage: Leksell GammaPlan is a computer-based system designed for June 27, 2018

Recent 510(k) Clearances

K-NumberDeviceDate
K190887Leksell Vantage Stereotactic SystemAugust 1, 2019
K173789Leksell Gamma Knife Perfexion, Leksell Gamma Knife IconMarch 30, 2018
K173791Leksell GammaPlanFebruary 9, 2018
K171123Leksell Vantage Stereotactic SystemSeptember 15, 2017
K160440Leksell Gamma Knife IconApril 20, 2016
K152558Leksell Stereotactic System, Injection/ Aspiration Needle KitMarch 2, 2016
K151159Leksell Gamma Knife PerfexionOctober 29, 2015
K151666Leksell GammaPlanSeptember 3, 2015
K151561Leksell Gamma Knife IconAugust 4, 2015
K133565LEKSELL GAMMA KNIFE PERFEXIONMay 9, 2014
K120811LEKSELL GAMMA KNIFE PERFEXIONMay 24, 2012
K103093LEKSELL GAMMAPLANDecember 21, 2010
K092083EXTEND FRAME SYSTEM, MODEL 1009633September 22, 2009
K090972LEKSELL GAMMAPLANJuly 20, 2009
K080355LEKSELL STEREOTACTIC SYSTEM WITH REUSABLE FIXATION SCREWSMay 1, 2009
K080250LEKSELL SURGIPLAN, MODEL 1006947May 13, 2008
K063512LEKSELL GAMMA KNIFE PERFEXIONMarch 5, 2007
K061941LEKSELL GAMMA KNIFE PERFEXION, MODEL 715000August 21, 2006
K061540LEKSELL GAMMAPLANJuly 5, 2006
K051746ELEKTA ESARTE FRAME SYSTEMJuly 25, 2005