FDAFDA · Food and drugs·Recall number Z-0231-2025
ClariTEE Probe- Miniature transesophageal echo ultrasound probe for use with ImaCor ultrasound diagnostic platforms. Model/Catalog Number: CLT-010, CLT-010-1
Published November 6, 2024 · Recall initiated: September 16, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- ImaCor Inc.
- Distributor
- FL ,GA, NJ, TN
- Lot
- UDI - Primary - 00861589000108 Lot numbers: 20250509 and 20250823
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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