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EOS Imaging recalls sterEOS workstation
Recalled September 26, 2018 · FDA recall Z-3188-2018 · EOS Imaging
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. · FDA Class II
Units
17 units
Sold at
US nationwide
Description
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.
Product
sterEOS workstation
Manufacturer(s)
EOS Imaging
Made in
France
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →