Brand
ImaCor Inc.
2 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for ImaCor Inc. and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-10-15FDA-DeviceClass IIClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniaturized TEE probe for use with Mobile Ultrasound, ImaCor model ZHH.
Production assembly error resulting in the potential for reversed articulation, where moving the lever forward caused the probe tip to anteflex rather than retroflex, and vice versa.
- 2024-11-06FDA-DeviceClass IIClariTEE Probe- Miniature transesophageal echo ultrasound probe for use with ImaCor ultrasound diagnostic platforms. Model/Catalog Number: CLT-010, CLT-010-1
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.
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