FDA-Device2014-01-01Class II
steroEOS Workstation with software versions: 1.3, 1.4 and 1.5 used in processing 3D X-ray images Product Usage: The sterEOS Workstation is a general system for acceptance , transfer, display and digital processing of two 3D x-ray images.
EOS Imaging
Hazard
Error copying information to the clinical file and to the report when two 3D models are opened simultaneously on the sterEOS workstation
Sold states
USA Nationwide Distribution
Affected count
36 units
Manufactured in
10 rue Mercoeur 4 Ieme Etage, N/A, Paris France, N/A, France
Products
steroEOS Workstation with software versions: 1.3, 1.4 and 1.5 used in processing 3D X-ray images Product Usage: The sterEOS Workstation is a general system for acceptance , transfer, display and digital processing of two 3D x-ray images.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0580-2014Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief