Home / Recalls / EOS Imaging / Z-0529-2014

Z-0529-2014 Class II Terminated

Recalled by EOS Imaging — Paris France

Recall Details

Product Type
Devices
Report Date
January 15, 2014
Initiation Date
November 7, 2013
Termination Date
January 27, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
22 EOS systems are installed in US

Product Description

EOS System X- ray beam Digital radiography system used in general radiographic examinations.

Reason for Recall

EOS imaging discovered during production internal testing that the X-ray beam collimation set up by the operator at the user interface of the acquisition workstation is different from the actual collimation of the X-ray beam operated by the EOS system during the X-ray acquisition.

Distribution Pattern

Nationwide Distribution

Code Information

EOS System

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-0580-2014 Class II — steroEOS Workstation with software versions: 1.3, 1.4 and 1.5 used in processing (November 29, 2013)
  • Z-2072-2012 Class II — EOS X-ray Medical Diagnostic , X-ray Equipment System Digital Radiography use (June 19, 2012)