Echopixel Recalls
2 recalls on record · May 28, 2025 to May 28, 2025 · Medical Devices
May 28, 2025Medical DevicesFDA
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 fo
Hazard: 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.
May 28, 2025Medical DevicesFDA
Echopixel, Inc. recalls True 3D Viewer, Model: EP-00003
Hazard: 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.