CLASS II ONGOING Device recall · Reported 28 May 2025 · FDA Enforcement Report

True 3d Viewer System recalled by Echopixel

Echopixel is recalling True 3d Viewer System, distributed nationwide in the US. The recall was initiated on 11 Apr 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel 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

Quantity recalled9 systems

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1807-2025
FDA event ID: 96629
Recalling firm: Echopixel, San Jose, CA
Classification: Class II
Status: Ongoing
Recall initiated: 11 Apr 2016
FDA classified: 21 May 2025
Reported: 28 May 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Device type: Imaging Equipment

Timeline

11 Apr 2016	Recall initiated by company
21 May 2025	Classified by FDA	+3327 days
28 May 2025	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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.

Where it was distributed

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

Nationwide California Florida Massachusetts New Jersey Ohio Pennsylvania

Questions about this recall

Is True 3d Viewer System recalled?

Yes. Echopixel recalled True 3d Viewer System on 11 Apr 2016. The recall is Class II and its status is Ongoing. Recall number Z-1807-2025.

Why was it recalled?

Which lots are affected?

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

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Echopixel

All 2

Reported	Class	Recall	Company	Reason	Where
28 May 2025Device	CLASS II	True 3D Viewer recalled by Echopixel	Echopixel	Device Malfunction	Nationwide

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