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TRUE 3D VIEWER SYSTEM Model Number EP-00001-XX recallZ-1807-2025 · Echopixel, Inc. · initiated Apr 11, 2016

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Echopixel, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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.

FDA root cause category: Software design

What the company is doing

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: [email protected] Phone: +1 (844) 273-7766

Recall details

Recall number
Z-1807-2025
Status
Open, Classified
Initiated by the company
Apr 11, 2016
Posted by the FDA
May 21, 2025
Recalling firm
Echopixel, Inc.
Quantity
9 systems
Product code
LLZ
FDA submissions
K142107
Distribution
Worldwide - U.S. Nationwide distribution in the states of CA, OH, NJ, PA, MA, FL and the country of Canada.

Product description

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.

Code information (models, lots, serial numbers)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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