Echopixel, Inc. recalls True 3D Viewer, Model: EP-00003

Recall date

February 21, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1785-2025

FDA classification

Class II

Brand / firm

Echopixel, Inc.

Sold / distributed

Worldwide - US Nationwide distribution in the states of CA, OH, NJ, PA, MA, FL, CT, TX, LA, MI, MN and the country of CA.

Why it was recalled

With certain software versions, import of enhanced ultrasound formatted data/ultrasound images into 3D viewer, (for digital image processing/review/analysis/communication/media interchange acquired from CT/MRI/ultrasound, and pre-operative analysis of surgical options), can result in incorrect display of image orientation, which could result in misdiagnosis or incorrect surgical treatment plan.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

True 3D Viewer, Model: EP-00003