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

FDA device recall Z-0231-2025 · posted 2024-10-25 · Open, Classified

Recall details

Recalling firm

ImaCor Inc.

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.

Action taken

ImaCor issued Inventory Correction for ImaCor ClariTEE Probe (CLT-010 and CLT-010-1) letter on 9/16/24. Letter states reason for recall, health risk and action to take: 1. Identify the Affected Devices o Please check your inventory for ClariTEE probes with lot numbers 20250509 and 20250823. Inform ImaCor of the number of applicable probes currently in inventory. 2. Prepare the Products for Return o Package the affected products securely to prevent damage during shipment. 3. Shipping Instructions o Please ship the affected products via FedEx using FedEx Account Number 665380920 to cover the shipping cost. Ship to: ImaCor Inc, 50 Jericho Turnpike, Suite 105, Jericho, NY 11753. Destination phone number is (516) 393-0970. o Attach a copy of this letter inside the package for reference. 4. Replacement Devices o Once we receive the returned devices, we will ship replacement probes to your facility. Replacement probes are expected to be available on or about October 15, 2024. Please return all affected devices by October 7. If you have any questions or need assistance, please contact Jenn Kujawski at jenn@imacorinc.com. Our team is ready to assist you with any inquiries and can provide additional details if needed.

Root cause

Process control

Status

Open, Classified

Product code

ITX

Quantity affected

73 units

Distribution

FL ,GA, NJ, TN

Date initiated

2024-09-16

Date posted

2024-10-25

Location

Jericho, NY

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