Recall Atlas

Echopixel recalls

2 official recalls and safety alerts involving Echopixel since 2025-05, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.

This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Echopixel or the relevant agency.

  1. 2025-05-28
  2. US
    Drugs & medicalClass II

    Echopixel, Inc. recalls 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…

    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.

    FDA · DeviceEchopixel, Inc.Worldwide - U.S. Nationwide distribution in the states of CA, OH, NJ, PA, MA,…Official notice →
  3. US
    Drugs & medicalClass II

    Echopixel, Inc. recalls True 3D Viewer, Model: EP-00003

    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…

    FDA · DeviceEchopixel, Inc.Worldwide - US Nationwide distribution in the states of CA, OH, NJ, PA, MA,…Official notice →