Z-0231-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- November 6, 2024
- Initiation Date
- September 16, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 73 units
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.
Distribution Pattern
FL ,GA, NJ, TN
Code Information
UDI - Primary - 00861589000108 Lot numbers: 20250509 and 20250823