Z-1785-2025Class II

True 3D Viewer, Model: EP-00003

Name: Z-1785-2025 True 3D Viewer, Model: EP-00003
Creator: Echopixel, Inc.
Published: 2018-02-21
License: https://open.fda.gov/license/

Echopixel, Inc. / initiated 2018-02-21 / Open, Classified / root cause: design

FDA source

Echopixel, Inc. began a recall of True 3D Viewer, Model: EP-00003 on 2018-02-21. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1785-2025
Classification: Class II
Status: Open, Classified
Initiated: 2018-02-21
Posted: 2025-05-16
Recalling firm: Echopixel, Inc.
Product: True 3D Viewer, Model: EP-00003
Product code: LLZ System, Image Processing, Radiological
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.
Root cause tag: design
FDA root cause: Device Design
Action: On 2/21/2018, correction notices were emailed to customers who were asked to do the following: a) Affected software versions should not be used with Enhanced 3D Ultrasound DICOM compliant volumes or Philips 3DDCM. b) If clinicians are utilizing Enhanced 3D Ultrasound DICOM compliant volumes or Philips 3DDCM volume data sets, verify, retrospectively, any potential risk to health to patients and further determine if patients need to be reevaluated and report this information to the firm. c) Pass a copy of this notice to those staff members who need to be aware of the issue and maintain awareness for a three-month period. d)If devices were transferred to other departments or organizations, provide a copy of this notice to these consignees. Firm will contact customers to provide information about the timing and delivery mechanisms of the software upgrade. If you have questions, contact the firm at: 1-844-273-7766 x2
Quantity in commerce: 18
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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1785-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1785-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-05-28	2025-05-16

Product code LLZ

K170167Class IITrue 3D Viewer SoftwareEchopixel, Inc. / cleared 2017-03-03

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)