01
Jan
2014

Cl II steroEOS Workstation

0

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

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About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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