Reported May 28, 2025 · Ongoing
TRUE 3D VIEWER SYSTEM Model Number EP-00001-XX Software versions 1.0, 1.25, and 1.35 The t3D-Viewer is designed for use…
Echopixel, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Echopixel, Inc. · 780 Montague Expy Ste 305 · San Jose, CA · 95131-1317
Is this the product you have?
- TRUE 3D VIEWER SYSTEM Model Number EP-00001-XX Software versions 1.0, 1.25, and 1.35 The t3D-Viewer is designed for use by health care professionals HCPs and is intended to assist the clinician who is responsible for making all patient management decisions. The True 3D Viewer (t3D-Viewer) system is comprised of a commercial off the shelf hardware platform and a proprietary software application that enables a health care professional (HCP) to visualize and interact with CT and MRI DICOM image data to assist in clinical decision making. The t3D-Viewer system hardware platform is comprised of an off the shelf stereoscopic display, an optical or electromagnetic motion tracking system and a computer system.
- Lot codes and dates
- Model Number EP-00001-XX with software versions 1.0, 1.25, and 1.35
- UDI-DI Codes00851325007003
- Serial NumbersField
- Products
C2015-09-0001C2015-09-0003D2015-05-0002C2015-06-0002D2015-12-0004C2015-08-0001D2015-12-0005C2015-09-0002D2015-12-0001C2016-01-0001D2015-12-0002C2015-12-0002D2015-12-0003D2016-01-0002
- Amount recalled
- 9 systems
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Imaging system data may be displayed with an incorrect orientation (sidedness) where the patient side is not correct (left, right, superior, inferior, anterior or posterior). This may lead to an inaccurate measurements.
This product could cause temporary or reversible health problems — stop using it.
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