medical Class II Updated 2018-09-26

EOS Imaging recalls sterEOS workstation

Recalled Product

sterEOS workstation


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: All software versions are impacted
View official government recall

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