Jericho, NY, US · 1 510(k) clearances · 2 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | Class II | Radiology | 1 | 2022-04-08 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2025-08-29 | Class II | Ongoing | Z-0038-2026 | ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniaturized TEE probe for use with Mobile Ultra… | — | Production assembly error resulting in the potential for reversed articulation, where moving the lever forward caused the probe tip to anteflex rather than retr… |
| 2024-09-16 | Class II | Ongoing | Z-0231-2025 | ClariTEE Probe- Miniature transesophageal echo ultrasound probe for use with ImaCor ultrasound diagnostic platforms. Mo… | — | Epoxy used to seal the edge of the transducer into its paddle exceeded specification. This variability could attenuate the ultrasound signal with a potential im… |