Device recall
Z-0231-2025: ClariTEE Probe- Miniature transesophageal echo ultrasound probe for use with…
FDA device recall · Class II · ImaCor Inc.
Key facts
| Recall number (Z-number) | Z-0231-2025 |
|---|---|
| Recall event | 95459 |
| Product | ClariTEE Probe- Miniature transesophageal echo ultrasound probe for use with ImaCor ultrasound diagnostic platforms. Model/Catalog Number: CLT-010, CLT-010-1 |
| Product code | ITX |
| Recalling firm | ImaCor Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K080223, K100989, K142054, K220490 |
| FEI number | 3006382185 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database