Recall Z-0231-2025— ImaCor Inc.
Class II · Ongoing
Class II FDA medical device recall by ImaCor Inc., initiated 2024-09-16. It names 4 FDA 510(k) clearances: K220490, K142054, K100989 and 1 more. Product: ClariTEE Probe- Miniature transesophageal echo ultrasound probe for use with ImaCor ultrasound diagnostic platforms. Model/Catalog Number: CLT-010, CLT-010-1. Reason: 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 from the probes..
- Recalling firm
- ImaCor Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-09-16
- Firm location
- Jericho, NY, United States
510(k) clearances named in this recall
4 on FDA's record- K220490 — ImaCor Zura Handheld ZHH-010
- K142054 — IMACOR ZURA EVO IMAGING SYSTEM
- K100989 — ZURA TEE SYSTEM WITH CLARITEE PROBE
- K080223 — ZURA TEE SYSTEM
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
ClariTEE Probe- Miniature transesophageal echo ultrasound probe for use with ImaCor ultrasound diagnostic platforms. Model/Catalog Number: CLT-010, CLT-010-1
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 from the probes.
Data sourced from openFDA. This site is unofficial and independent of the FDA.