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-010CLT-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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