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Echopixel, Inc. recalls True 3D Viewer, Model: EP-00003
Recalled May 28, 2025 · FDA recall Z-1785-2025 · Echopixel
Hazard
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. · FDA Class II
Units
18
Sold at
Worldwide - US Nationwide distribution in the states of CA, OH, NJ, PA, MA, FL, CT, TX, LA, MI, MN and the country of CA.
Description
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.
Product
True 3D Viewer, Model: EP-00003
Manufacturer(s)
Echopixel, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →