Echopixel, Inc.: 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.

Recall number

Z-1807-2025

Recalling firm

Echopixel, Inc.

Product

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.

Status

Open, Classified

Initiated

2016-04-11

Posted

2025-05-21

Terminated

not on file

Reason

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.

Root cause

Software design

Action

On 03/25/2026, the firm sent via email and telephone an Urgent Field Safety Notice, informing customers of a potential misdiagnosis or incorrect surgical treatment planning approach can result when utilizing Enhanced Multi-frame DICOM image data sets. Customers were instructed to: verify if Enhanced Multi-Frame CT DICOM files have been used with the software. If users have utilized this file type, we request that users verify retrospectively any potential risk to health of patients and further determine if this patient needs to be reevaluated and report it to EchoPixel, Inc. We request that the True 3D Viewer versions 1.0, 1.25, 1.35 NOT be used with this file type. For any questions or concerns - contact EchoPixel, Inc Monday thru Friday 9 AM - 6 PM Pacific at: Mailing address: 2490 Hospital Dr. Suite 310, Mountain View CA 94040 Email: support@echopixeltech.com Phone: +1 (844) 273-7766

Quantity

9 systems

Distribution

Worldwide - U.S. Nationwide distribution in the states of CA, OH, NJ, PA, MA, FL and the country of Canada.

Lot, serial or model codes

Model Number EP-00001-XX with software versions 1.0, 1.25, and 1.35 UDI-DI Codes: 00851325007003 Serial Numbers: Field Products: C2015-09-0001 C2015-09-0003 D2015-05-0002 C2015-06-0002 D2015-12-0004 C2015-08-0001 D2015-12-0005 C2015-09-0002 D2015-12-0001 C2016-01-0001 D2015-12-0002 C2015-12-0002 D2015-12-0003 D2016-01-0002

510(k) numbers

["K142107"]

PMA numbers

not on file

Product code

LLZ

Firm FEI

3011501361

Firm city

San Jose

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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