Product Wiki · Recalls · U.S. FDA — Device Enforcement

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. — recall Z-0580-2014

U.S. FDA — Device Enforcement · France · 2013-11-29 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0580-2014
Date of alert
2013-11-29
Country / jurisdiction
France
Risk level
Class II
Risk type
recall
Brand
EOS Imaging
Product category
device
Product type
Devices
Reported risk: Error copying information to the clinical file and to the report when two 3D models are opened simultaneously on the sterEOS workstation
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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