FDA recall Z-0231-2025

Product

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.

Distribution

FL ,GA, NJ, TN

Key facts

Status

Ongoing

Initiation date

2024-09-16

Report date

2024-11-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Jericho, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0231-2025