Home / Recalls / EOS Imaging / Z-0580-2014

Z-0580-2014 Class II Terminated

Recalled by EOS Imaging — Paris France, N/A

Recall Details

Product Type
Devices
Report Date
January 1, 2014
Initiation Date
November 29, 2013
Termination Date
January 13, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
36 units

Product Description

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.

Reason for Recall

Error copying information to the clinical file and to the report when two 3D models are opened simultaneously on the sterEOS workstation

Distribution Pattern

USA Nationwide Distribution

Code Information

Software versions: 1.3, 1.4 and 1.5

Other recalls by EOS Imaging

  • Z-1415-2021 Class II — The EOSedge system may acquire two simultaneous orthogonal planar images for a s (December 22, 2020)
  • Z-3188-2018 Class II — sterEOS workstation (August 1, 2018)
  • Z-2626-2017 Class II — ROTH MOBELI Grab Handles used with EOS System: MOBELI Stabi Vario Grab Handle, R (May 30, 2017)
  • Z-1460-2015 Class II — EOS, Digital radiography system used in general radiographic examinations. (February 17, 2015)
  • Z-0529-2014 Class II — EOS System X- ray beam Digital radiography system used in general radiographi (November 7, 2013)
  • Z-2072-2012 Class II — EOS X-ray Medical Diagnostic , X-ray Equipment System Digital Radiography use (June 19, 2012)