ClariTEE Probe Ultrasound Recall Due to Defective Epoxy Sealing
ImaCor is recalling 73 ClariTEE Probe ultrasound units due to defective epoxy sealing that could degrade diagnostic image quality. The affected units were distributed in Florida, Georgia, New Jersey, and Tennessee.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall involves a diagnostic medical device where the manufacturing defect could degrade image quality through signal attenuation. Although no illnesses or injuries have been reported, it qualifies as a risk-of-harm product where diagnostic capability may be compromised.
Plain-English summary
ImaCor Inc. is recalling 73 ClariTEE Probe transesophageal echo ultrasound probes (Models CLT-010 and CLT-010-1) used with ImaCor diagnostic ultrasound platforms.
The epoxy used to seal the edge of the transducer into the probe's paddle exceeded manufacturing specifications. This defect could attenuate the ultrasound signal, potentially reducing the quality of diagnostic images obtained from the affected probes.
The recalled probes were distributed in Florida, Georgia, New Jersey, and Tennessee. The affected lot numbers are 20250509 and 20250823.
The recalled product
- Product
- ClariTEE Probe- Miniature transesophageal echo ultrasound probe for use with ImaCor ultrasound diagnostic platforms. Model/Catalog Number: CLT-010, CLT-010-1
- Manufacturer
- ImaCor Inc.
- Affected units
- 73
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI - Primary - 00861589000108 Lot numbers: 20250509 and 20250823
Distribution
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