Recall Z-0580-2014 ยท LLZ System, Image Processing, Radiological
EOS Imaging
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.
| Date | Dec 26, 2013 (initiated Nov 29, 2013) |
| Status | Terminated |
| Reason | Error copying information to the clinical file and to the report when two 3D models are opened simultaneously on the sterEOS workstation |
| Root cause | Software design |
| Action | 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 simul |
| Quantity | 36 units |
| Distribution | USA Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K130395 | STEREOS WORKSTATION Eos Imaging, Inc., Mar 11, 2013 |