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.
This recall has been terminated (originally issued December 26, 2013).
- Recall Initiated
- November 29, 2013
- Posted
- December 26, 2013
- Terminated
- January 13, 2015
- Recall Number
- Z-0580-2014
- Quantity
- 36 units
- Official Source
- View on FDA website ↗
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
USA Nationwide Distribution
Lot / Code Info
Software versions: 1.3, 1.4 and 1.5
Root Cause
Software design
Action Taken
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.