ClariTEE Probe- Miniature transesophageal echo ultrasound probe for use with ImaCor ultrasound diagnostic platforms. Model/Catalog Number: CLT-010, CLT-010-1
Reported: November 6, 2024 Initiated: September 16, 2024 #Z-0231-2025
Product Description
ClariTEE Probe- Miniature transesophageal echo ultrasound probe for use with ImaCor ultrasound diagnostic platforms. Model/Catalog Number: CLT-010, CLT-010-1
Reason for Recall
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.
Details
- Recalling Firm
- ImaCor Inc.
- Units Affected
- 73 units
- Distribution
- FL ,GA, NJ, TN
- Location
- Jericho, NY
Frequently Asked Questions
What product was recalled? ▼
ClariTEE Probe- Miniature transesophageal echo ultrasound probe for use with ImaCor ultrasound diagnostic platforms. Model/Catalog Number: CLT-010, CLT-010-1. Recalled by ImaCor Inc.. Units affected: 73 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 6, 2024. Severity: Moderate. Recall number: Z-0231-2025.
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