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
- Recall Number
- Z-0580-2014
- Event Number
- 66980
- FEI Number
- 3006165260
- Product Code
- LLZ
- Status
- Terminated
- Root Cause
- Software design
- Initiated
- November 29, 2013
- Posted
- December 26, 2013
- Terminated
- January 13, 2015
- Address
- EOS Imaging 10 rue Mercoeur 4 Ieme Etage Paris France France
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.
Error copying information to the clinical file and to the report when two 3D models are opened simultaneously on the sterEOS workstation
EOS imaging issued a safety information letter dated November 29, 2013, to the US customer sites. The letter identifed the affected product, problem and actions to be taken. Users of the sterEOS workstation are asked not to simultaneously open several pairs of images in sterEOS 3D. The letter informed customers that EOS imaging will, at it's own expense, corect all systems affected by means of a software update. An EOS imaging representative will contact affected customers to make an appointment for this update once it is available. Users of the sterEOS workstation are asked not to simultaneously open several pairs of images in sterEOS 3D. For questions call +33 (0) 155 25 6060.
USA Nationwide Distribution
36 units