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2 recalls •

🏥 Medical Devices

• Categories: Other Medical Devices

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 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 image data to assist in clinical decision making. The t3D-Viewer system hardware platform is comprised of an off the shelf stereoscopic display, an optical or electromagnetic motion tracking system and a computer system.

Class I - Dangerous

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.

Apr 11, 2016 Other Medical Devices Nationwide View Details →

True 3D Viewer, Model: EP-00003

Class I - Dangerous

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.

Feb 21, 2018 Other Medical Devices Nationwide View Details →