FDAFebruary 21, 2018device
True 3D Viewer, Model: EP-00003
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
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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