FDA Recall: Import of enhanced ultrasound formatted data can result in incorrect display of image orientation

Company: Echopixel, Inc.
Date of Enforcement Report: 5/16/2025
Class II

PRODUCT

True 3D Viewer, Model: EP-00003

Recall Number:

Z-1785-2025

REASON:

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.

RECALLING FIRM/MANUFACTURER:

Echopixel, Inc.

VOLUME:

18

DISTRIBUTION:

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

About the author

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

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