Recall Z-1807-2025— Echopixel, Inc.

Name: FDA recall Z-1807-2025
Creator: U.S. Food and Drug Administration
Published: 2016-04-11

Class II · Ongoing

Class II FDA medical device recall by Echopixel, Inc., initiated 2016-04-11. It names one FDA 510(k) clearance: K142107. 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.. 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: Echopixel, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2016-04-11
Firm location: San Jose, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K142107 — ECHO TRUE 3D VIEWEREchopixel, Inc.·cleared 2015-01-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.