ImaCor Inc.: ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniaturized TEE probe for use with Mobile Ultrasound, ImaCor model ZHH.

Hazard

Production assembly error resulting in the potential for reversed articulation, where moving the lever forward caused the probe tip to anteflex rather than retroflex, and vice versa.

Details from the source

Reason for recall: Production assembly error resulting in the potential for reversed articulation, where moving the lever forward caused the probe tip to anteflex rather than retroflex, and vice versa. Distribution: US Nationwide distribution in the states of South Carolina, New Jersey, Pennsylvania, Florida, and Georgia. Quantity: 45 units Lot/code info: Model CLT-010; UDI-DI 00861589000108; Lot number: 20261209.

UPC codes

00861589000108

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.