Elekta Instrument AB
FDA Regulatory Profile
Elekta Instrument AB appears in FDA public data with 5 recalls — including 2 Class I (most serious) —, 35 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0227-2025, Class I) was initiated on September 25, 2024. Its most recent 510(k) clearance was granted on August 1, 2019.
Summary
- Total Recalls
- 5 (2 Class I)
- 510(k) Clearances
- 35
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0227-2025 | Class I | Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, Diameter / 14 Gaug | September 25, 2024 |
| Z-1397-2024 | Class I | Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, 2.1mm Diameter / 14 | March 15, 2024 |
| Z-1309-2023 | Class II | Instructions for Use for the following Leksell Stereotactic System and Leksell Neurosurgical Instrum | March 1, 2023 |
| Z-2442-2020 | Class II | Leksell Vantage Stereotactic System, UDI/GTIN 7340048304887 | June 10, 2020 |
| Z-1412-2019 | Class II | Leksell GammaPlan 11.1 Product Usage: Leksell GammaPlan is a computer-based system designed for | June 27, 2018 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K190887 | Leksell Vantage Stereotactic System | August 1, 2019 |
| K173789 | Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon | March 30, 2018 |
| K173791 | Leksell GammaPlan | February 9, 2018 |
| K171123 | Leksell Vantage Stereotactic System | September 15, 2017 |
| K160440 | Leksell Gamma Knife Icon | April 20, 2016 |
| K152558 | Leksell Stereotactic System, Injection/ Aspiration Needle Kit | March 2, 2016 |
| K151159 | Leksell Gamma Knife Perfexion | October 29, 2015 |
| K151666 | Leksell GammaPlan | September 3, 2015 |
| K151561 | Leksell Gamma Knife Icon | August 4, 2015 |
| K133565 | LEKSELL GAMMA KNIFE PERFEXION | May 9, 2014 |
| K120811 | LEKSELL GAMMA KNIFE PERFEXION | May 24, 2012 |
| K103093 | LEKSELL GAMMAPLAN | December 21, 2010 |
| K092083 | EXTEND FRAME SYSTEM, MODEL 1009633 | September 22, 2009 |
| K090972 | LEKSELL GAMMAPLAN | July 20, 2009 |
| K080355 | LEKSELL STEREOTACTIC SYSTEM WITH REUSABLE FIXATION SCREWS | May 1, 2009 |
| K080250 | LEKSELL SURGIPLAN, MODEL 1006947 | May 13, 2008 |
| K063512 | LEKSELL GAMMA KNIFE PERFEXION | March 5, 2007 |
| K061941 | LEKSELL GAMMA KNIFE PERFEXION, MODEL 715000 | August 21, 2006 |
| K061540 | LEKSELL GAMMAPLAN | July 5, 2006 |
| K051746 | ELEKTA ESARTE FRAME SYSTEM | July 25, 2005 |