Reported Nov 6, 2024 · Ongoing

ClariTEE Probe- Miniature transesophageal echo ultrasound probe for use with ImaCor ultrasound diagnostic platforms.…

ImaCor Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: ImaCor Inc. · 50 Jericho Tpke Ste 105 · Jericho, NY · 11753-1014

Is this the product you have?

  • ClariTEE Probe- Miniature transesophageal echo ultrasound probe for use with ImaCor ultrasound diagnostic platforms
  • Model/Catalog Number
    • CLT-010
    • CLT-010-1
Lot codes and dates
  • UDI -
  • Primary - 00861589000108 Lot numbers20250509 and 20250823
Amount recalled
73 units

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:18 PM UTC

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