Drug recall
ClariTEE Probe- Miniature transesophageal echo ultrasound probe for use with ImaCor ultrasound diagnostic…
FDA recall event 95459 · Class II · ImaCor Inc.
Key facts
| Event ID | 95459 |
|---|---|
| Recall numbers | Z-0231-2025 |
| Recalling firm | ImaCor Inc. |
| Product type | Devices |
| Products | ClariTEE Probe- Miniature transesophageal echo ultrasound probe for use with ImaCor ultrasound diagnostic platforms. Model/Catalog Number: CLT-010, CLT-010-1 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Epoxy used to seal the edge of the transducer into its paddle exceeded specification. This variability could attenuate the ultrasound signal with a potential impact on the quality of images obtained… |
| Initiation date | Sep 16, 2024 |
| Report date | Nov 6, 2024 |
| City | Jericho |
| State | NY |
| Country | United States |
| FEI number | 3006382185 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: