Elekta Limited
Summary
- Total Recalls
- 6
- 510(k) Clearances
- 8
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-2297-2020 | Class II | Elekta Unity, Philips Marlin Software versions: R5.3.30, R5.3.31, R6.0.5331, R5.7.0, R5.7.1, R6.1.57 | May 21, 2020 |
| Z-1297-2019 | Class II | Elekta Unity systems Product Usage: Elekta Unity using Magnetic Resonance Imaging is indicated f | April 3, 2019 |
| Z-1109-2019 | Class II | Elekta Unity, Image-Guided Radiation Therapy System Product Usage: Elekta Unity using Magnetic R | March 12, 2019 |
| Z-0706-2019 | Class II | Elekta Unity | January 4, 2019 |
| Z-0724-2018 | Class II | Integrity R1.2 | November 20, 2017 |
| Z-0723-2018 | Class II | Agility with Integrity R3.2 | November 20, 2017 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K210500 | Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD | June 11, 2021 |
| K192482 | Elekta Unity | December 5, 2019 |
| K192242 | Synergy Platform, Synergy, Infinity, VersaHD | November 22, 2019 |
| K182076 | Elekta Unity | December 4, 2018 |
| K153011 | iViewDose R1.0 | December 11, 2015 |
| K131965 | XVI R5.0 | September 25, 2013 |
| K112613 | INTEGRITY(TM) | December 16, 2011 |
| K111676 | APEX | September 30, 2011 |