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.
