FDA-Device2018-09-26Class II
sterEOS workstation
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.
Sold states
US nationwide
Affected count
17 units
Manufactured in
4 Ieme Etage, 10 Rue Mercoeur, Paris, N/A, France
Products
sterEOS workstation
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3188-2018Don't want to check this manually?
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