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FDAAugust 1, 2018device

sterEOS workstation

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

3D projections may be incorrect when the pair of images used is a secondary capture generated from a series containing more than two images, where one of the images has been manually flipped. Projection errors may lead to errors in calculation of 3D clinical parameters when adjusting the position, size and shape of the 3D objects used. Incorrect clinical parameters can be a contributing factor in incorrect clinical decisions, or sub-optimal surgical interventions.

What to do

FDA enforcement status: Terminated

Brands named

eos imagingeos

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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