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True 3D Viewer EP-00003Recalls & reported problems

Echopixel, Inc. · Software: The True 3D Viewer Software is intended for processing, review, analysis, communication and media interchange of digital images acquired from CT, MRI and Ultrasound sources. It is also intended as software for pre-operative analysis of surgical options. The True 3D Viewer Software is designed for use only with performance tested hardware specified in the user documentation. The device is intended to be used by health care professionals, who are responsible for making all final patient management decisions. · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
2

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00851325007003), received between Feb 22, 2018 and Feb 22, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Programming Issue” (1 report).

2 FDA recall records name this device's identifier, 2 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

  1. Feb 21, 2018Class IIOpen, Classified

    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.

    Z-1785-2025 · Root cause: Device Design · Recall details · FDA record ↗

  2. Apr 11, 2016Class IIOpen, Classified

    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.

    Z-1807-2025 · Root cause: Software design · Recall details · FDA record ↗

Most reported problems

Device problems

  • Programming Issue1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionFeb 22, 2018Programming Issue; Programming Issue

    NO KNOWN EVENT OCCURRED. PROBLEM: THE IMPORT OF ENHANCED ULTRASOUND FORMATTED DATA (NEMA DICOM SUPPLEMENT 43: STORAGE OF 3D ULTRASOUND DATA, VERSION: FINAL TEXT - (B)(6) 2009), CAN RESULT IN INCORRECT DISPLAY OF IMAGE ORIENTATION. THE REASON WAS AN INCORRECT UNDERSTANDING OF THE DATA FORMAT. THIS FAULT DOES NOT RESIDE IN THE TRUE 3D RENDER ENGINE, BUT RATHER IS LOCALIZED TO THE DICOM INPUT TASK OF THE APPLICATION PROBLEM: THE IMPORT OF PHILIPS 3DDCM FORMATTED ULTRASOUND IMAGES CAN RESULT IN INCORRECT DISPLAY OF IMAGE ORIENTATION. THE REASON WAS AN INCORRECT UNDERSTANDING OF THE DATA FORMAT. THIS FAULT DOES NOT RESIDE IN THE TRUE 3D RENDER ENGINE, BUT RATHER IS LOCALIZED TO THE DICOM INPUT TASK OF THE APPLICATION. ISSUE WAS IDENTIFIED ON RELEASE VERSIONS: 1.6.1 AND 1.6.2.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7290502 ↗

Other System, Image Processing, Radiological devices

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Sources and updates

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