Device product
ClariTEE Probe- Miniature transesophageal echo ultrasound probe for use with ImaCor ultrasound diagnostic platforms. Model/Catalog Number: CLT-010, CLT-010-1
Z-0231-2025
Product summary
- Firm
- ImaCor Inc.
- Event
- Event 95459
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 73 units
- Official record key
device-enforcement:Z-0231-2025
Official wording
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.
Code information: UDI - Primary - 00861589000108 Lot numbers: 20250509 and 20250823
Distribution pattern: FL ,GA, NJ, TN
Derived failure modes
-
Unknown
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.