FDAApril 11, 2016device
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 ...
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Ongoing
Brands named
echopixel
UPCs
00851325007003
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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