Echopixel, Inc.
2 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Echopixel, Inc. and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-05-28FDA-DeviceClass IITRUE 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 professionals HCPs and is intended to assist the clinician who is responsible for making all patient management decisions. The True 3D Viewer (t3D-Viewer) system is comprised of a commercial off the shelf hardware platform and a proprietary software application that enables a health care professional (HCP) to visualize and interact with CT and MRI DICOM
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.
- 2025-05-28FDA-DeviceClass IITrue 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 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.
Get notified about new Echopixel, Inc. recalls
Free weekly digest. We email when a new federal recall affects Echopixel, Inc. or anything else in your household.
Get the Sunday Brief