Company: EOS Imaging
Date of Enforcement Report:1/1/2014
Class lI:
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.
Recall Number Z-0580-2014
REASON
Error copying information to the clinical file and to the report when two 3D models are opened simultaneously on the sterEOS workstation
RECALLING FIRM/MANUFACTURER
EOS Imaging, Paris, France on 11/29/2013. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
36 units
DISTRIBUTION
Nationwide
___________________________________
