EOS Imaging
Summary
- Total Recalls
- 7
- 510(k) Clearances
- 17
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-1415-2021 | Class II | The EOSedge system may acquire two simultaneous orthogonal planar images for a standing or seated pa | December 22, 2020 |
| Z-3188-2018 | Class II | sterEOS workstation | August 1, 2018 |
| Z-2626-2017 | Class II | ROTH MOBELI Grab Handles used with EOS System: MOBELI Stabi Vario Grab Handle, ROTH Catalogue Number | May 30, 2017 |
| Z-1460-2015 | Class II | EOS, Digital radiography system used in general radiographic examinations. | February 17, 2015 |
| Z-0580-2014 | Class II | steroEOS Workstation with software versions: 1.3, 1.4 and 1.5 used in processing 3D X-ray images | November 29, 2013 |
| Z-0529-2014 | Class II | EOS System X- ray beam Digital radiography system used in general radiographic examinations. | November 7, 2013 |
| Z-2072-2012 | Class II | EOS X-ray Medical Diagnostic , X-ray Equipment System Digital Radiography used in general radiogr | June 19, 2012 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K251078 | AutoDensity | November 14, 2025 |
| K251747 | VEA Align; spineEOS | August 15, 2025 |
| K233920 | EOSedge | August 6, 2024 |
| K240582 | VEA Align; spineEOS | June 25, 2024 |
| K231917 | VEA Align | January 5, 2024 |
| K232086 | spineEOS | October 24, 2023 |
| K202394 | EOSedge | September 16, 2020 |
| K192079 | EOSedge | November 27, 2019 |
| K172346 | sterEOS Workstation | June 19, 2018 |
| K160914 | sterEOS Workstation | April 22, 2016 |
| K152788 | EOS System | October 21, 2015 |
| K142773 | EOS System | January 22, 2015 |
| K141137 | STEREOS WORKSTATION | September 15, 2014 |
| K130395 | STEREOS WORKSTATION | March 11, 2013 |
| K123740 | EOS | February 22, 2013 |
| K113344 | STEREOS WORKSTATION | November 16, 2012 |
| K120721 | EOS | April 6, 2012 |