TRUE 3D VIEWER SYSTEM Model Number EP-00001-XX Software versions 1.0, 1.25, and 1.35 The t3D-Viewer is designed fo
Summary
The FDA issued a Class II for TRUE 3D VIEWER SYSTEM Model Number EP-00001-XX Software versions 1.0, 1.25, a by Echopixel, Inc.. Reason: Imaging system data may be displayed with an incorrect orientation (sidedness) where the patient side is not correct (left, right, superior, inferior,.
Details
Source
Device Recall
External ID
Z-1807-2025
Action Date
2025-05-28
Status
Ongoing
Category
device
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.
Lot/Code Info: 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
Quantity Affected: 9 systems
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.
Distribution
Worldwide - U.S. Nationwide distribution in the states of CA, OH, NJ, PA, MA, FL and the country of Canada.
Type: Voluntary: Firm initiated
Recall Initiated: 2016-04-11
Company
San Jose, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 147 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Echopixel, Inc. has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Echopixel, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Echopixel, Inc. have FDA actions?
Echopixel, Inc. has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1807-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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