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U.S. Department of Health and Human Services

Class 2 Device Recall True 3D Viewer Versions 1.6.1, 1.6.2

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 Class 2 Device Recall True 3D Viewer Versions 1.6.1, 1.6.2see related information
Date Initiated by FirmFebruary 21, 2018
Date PostedMay 16, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1785-2025
Recall Event ID 96674
510(K)NumberK170167 
Product Classification System, image processing, radiological - Product Code LLZ
ProductTrue 3D Viewer, Model: EP-00003
Code Information 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
FEI Number 3011501361
Recalling Firm/
Manufacturer		 Echopixel, Inc.
780 Montague Expy Ste 305
San Jose CA 95131-1317
For Additional Information Contact
650-338-2559
Manufacturer 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.
FDA Determined
Cause 2		Device Design
ActionOn 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 Commerce18
DistributionWorldwide - US Nationwide distribution in the states of CA, OH, NJ, PA, MA, FL, CT, TX, LA, MI, MN and the country of CA.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = LLZ
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