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RecallWatchMedical Device Safety
Class IIOngoingZ-1807-2025

Echopixel, Inc. recalls TRUE 3D VIEWER SYSTEM Model Number EP-00001-XX Software versions 1.0

Echopixel, Inc.San Jose, CA, United StatesReported May 28, 2025 · 1 year ago
Legal News Analyst ·

Reason for recall

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.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • 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
    UDI-DI CodesModel Number
    14 affected lots
    C2015-09-0001C2015-09-0003D2015-05-0002C2015-06-0002D2015-12-0004C2015-08-0001D2015-12-0005C2015-09-0002
    +6 moreD2015-12-0001C2016-01-0001D2015-12-0002C2015-12-0002D2015-12-0003D2016-01-0002

What the firm 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: support@echopixeltech.com Phone: +1 (844) 273-7766

DistributionShow details

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

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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