Company: Echopixel, Inc.
Date of Enforcement Report: 5/21/2025
Class II
PRODUCT
TRUE 3D VIEWER SYSTEM Model Number EP-00001-XX Software versions 1.0, 1.25, and 1.35 The t3D-Viewer is designed for use by health care professionals HCPs and is intended to assist the clinician who is responsible for making all patient management decisions. The True 3D Viewer (t3D-Viewer) system is comprised of a commercial off the shelf hardware platform and a proprietary software application that enables a health care professional (HCP) to visualize and interact with CT and MRI DICOM image data to assist in clinical decision making. The t3D-Viewer system hardware platform is comprised of an off the shelf stereoscopic display, an optical or electromagnetic motion tracking system and a computer system
Recall Number:
Z-1807-2025
REASON:
Imaging system data may be displayed with an incorrect orientation (sidedness) where the patient side is not correct (left, right, superior, inferior, anterior or posterior). This may lead to an inaccurate measurements.
RECALLING FIRM/MANUFACTURER:
Echopixel, Inc.
VOLUME:
9 systems
DISTRIBUTION:
Worldwide – U.S. Nationwide distribution in the states of CA, OH, NJ, PA, MA, FL and the country of Canada.
