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EOS Imaging recalls steroEOS Workstation with software versions: 1.3, 1.4 and 1.5 used in processing 3D X-ray images Product Usage: The
Recalled January 1, 2014 · FDA recall Z-0580-2014 · 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 · FDA Class II
Units
36 units
Sold at
USA Nationwide Distribution
Description
Error copying information to the clinical file and to the report when two 3D models are opened simultaneously on the sterEOS workstation
Product
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.
Manufacturer(s)
EOS Imaging
Made in
France
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →