Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
True 3D Viewer Recalled by Echopixel, Inc. Due to With certain software versions, import of enhanced ultrasound...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Echopixel, Inc. directly.
Affected Products
True 3D Viewer, Model: EP-00003
Quantity: 18
Why Was This 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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Echopixel, Inc.
Echopixel, Inc. has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report