Z-1807-2025Class II

TRUE 3D VIEWER SYSTEM Model Number EP-00001-XX Software versions 1.0, 1.25, and 1.35 The t3D-Viewer is...

Name: Z-1807-2025 TRUE 3D VIEWER SYSTEM Model Number EP-00001-XX Software versions 1.0, 1.25, and 1.35 The t3D-Viewer is...
Creator: Echopixel, Inc.
Published: 2016-04-11
License: https://open.fda.gov/license/

Echopixel, Inc. / initiated 2016-04-11 / Open, Classified / root cause: software

FDA source

Echopixel, Inc. began a recall of 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... on 2016-04-11. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1807-2025
Classification: Class II
Status: Open, Classified
Initiated: 2016-04-11
Posted: 2025-05-21
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.
Product code: LLZ System, Image Processing, Radiological
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.
Root cause tag: software
FDA 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: [email protected] Phone: +1 (844) 273-7766
Quantity in commerce: 9 systems
Distribution: Worldwide - U.S. Nationwide distribution in the states of CA, OH, NJ, PA, MA, FL and the country of Canada.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1807-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1807-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-05-28	2025-05-21

Product code LLZ

K142107Class IIEcho True 3D ViewerEchopixel, Inc. / cleared 2015-01-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)