Home / Recalls / EOS Imaging / Z-3188-2018

Z-3188-2018 Class II Terminated

Recalled by EOS Imaging — Paris, N/A

Recall Details

Product Type
Devices
Report Date
September 26, 2018
Initiation Date
August 1, 2018
Termination Date
August 15, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
17 units

Product Description

sterEOS workstation

Reason for Recall

3D projections may be incorrect when the pair of images used is a secondary capture generated from a series containing more than two images, where one of the images has been manually flipped. Projection errors may lead to errors in calculation of 3D clinical parameters when adjusting the position, size and shape of the 3D objects used. Incorrect clinical parameters can be a contributing factor in incorrect clinical decisions, or sub-optimal surgical interventions.

Distribution Pattern

US nationwide

Code Information

All software versions are impacted

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-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-0580-2014 Class II — steroEOS Workstation with software versions: 1.3, 1.4 and 1.5 used in processing (November 29, 2013)
  • 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)