Summary
The FDA issued a Class II for True 3D Viewer, Model: EP-00003 by Echopixel, Inc.. Reason: With certain software versions, import of enhanced ultrasound formatted data/ultrasound images into 3D viewer, (for digital image processing/review/an.
Details
Source
Device Recall
External ID
Z-1785-2025
Action Date
2025-05-28
Status
Ongoing
Category
device
Product Description
True 3D Viewer, Model: EP-00003
Lot/Code Info: UDI-DI: 00851325007003. Full release software versions: 1.6.1.3080.428, released 13-Apr-2017 1.6.2.3670.435, released 07-Dec-2017 Develop Versions, for research use: 0.00.2695.422, released 15-Feb-2017 0.00.2927.423, released 15-Feb-2017 0.00.2964.423, released 24-Feb-2017 0.00.3102.428, released 04-Apr-2017 0.00.3245.428, released 05-May-2017 0.00.3302.431, released 02-Jun-2017 0.00.3344.432, released 18-Jul-2017 0.00.3412.433, released 14-Aug-2017 0.00.3656.442, released 09-Nov-2017 0.00.3669.442, released 05-Dec-2017 0.00.3683.445, released 02-Jan-2018 0.00.3702.447, released 11-Jan-2018 0.00.3730.447, released 08-Feb-2018
Quantity Affected: 18
Reason for Recall
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.
Distribution
Worldwide - US Nationwide distribution in the states of CA, OH, NJ, PA, MA, FL, CT, TX, LA, MI, MN and the country of CA.
Type: Voluntary: Firm initiated
Recall Initiated: 2018-02-21
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-1785-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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