Esaote S.p.A.
Summary
- Total Recalls
- 9
- 510(k) Clearances
- 66
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-1490-2026 | Class II | Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038 | March 14, 2025 |
| Z-3052-2020 | Class II | AC/DC POWER SUPPLY for 7400, Part Number 151004300, XP Power Model Number AHM180PS19-XE0338, AC/DC A | September 8, 2020 |
| Z-3053-2020 | Class II | AC/DC POWER SUPPLY for 7400, Part Number 151004301, XP Power Model Number AHM180PS19-XE1057, AC/DC A | September 8, 2020 |
| Z-0205-2019 | Class II | MyLab Gamma, Model 7410 | June 11, 2018 |
| Z-0206-2019 | Class II | MyLab Seven, Model 6400 | June 11, 2018 |
| Z-0204-2019 | Class II | MyLab Alpha, Model 7400 | June 11, 2018 |
| Z-1137-2018 | Class II | MyLab Ultrasound System; Models 6100, 6150, 6200, 6250; PA023E Probe 7.5/10 | January 3, 2018 |
| Z-1138-2018 | Class II | MyLab Ultrasound System; Models 6100, 6150, 6200, 6250; Probes: BL433, C 18, CA541, EC1123, EC123, I | January 3, 2018 |
| Z-2124-2016 | Class II | Magnetic Resonance System G-scan Brio (Part Number /Model No.101002000) | June 6, 2016 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K251901 | Magnifico Open (100009900) | March 5, 2026 |
| K253310 | 7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30) | November 25, 2025 |
| K243253 | 6600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70) | June 18, 2025 |
| K241671 | 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) | May 16, 2025 |
| K241133 | Magnifico Open (100009900); Magnifico MSK ( 100009910) | June 26, 2024 |
| K230179 | 6440 MyLabX90 | November 29, 2023 |
| K212419 | Magnifico Open, Magnifico MSK | February 4, 2022 |
| K212021 | 6430 MyLabX75, 6430 MyLab XPro75 | September 16, 2021 |
| K192157 | 6450 Ultrasound system | November 22, 2019 |
| K191072 | 7410 Ultrasound System (MyLabSigma) | June 10, 2019 |
| K190989 | 6400 Ultrasound System (MyLabX6, MyLabX7) | May 10, 2019 |
| K183685 | O-Scan | January 22, 2019 |
| K183191 | 6420 Ultrasound System | December 4, 2018 |
| K180592 | G-scan Brio | March 30, 2018 |
| K173291 | 6440 Ultrasound System | January 12, 2018 |
| K163082 | 6200 Ultrasound System and 6250 Ultrasound System | March 16, 2017 |
| K161973 | G-scan Brio, S-scan | October 25, 2016 |
| K162290 | MyLabSix CrystaLine | October 14, 2016 |
| K161359 | 6400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound System | July 19, 2016 |
| K161238 | S-scan | July 8, 2016 |