FDA Medical devices recall ·
True 3D Viewer, Model: EP-00003 recall
- Recall number
- Z-1785-2025
- Date
- (initiated February 21, 2018)
- Company / brand
- Echopixel, Inc.
780 Montague Expy Ste 305, San Jose, CA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 18
- Hazard tags
- Software
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
True 3D Viewer, Model: EP-00003
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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
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.
States: California Connecticut Florida Louisiana Massachusetts Michigan Minnesota New Jersey Ohio Pennsylvania Texas
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1785-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.