Recall Z-1577-2009 ยท LLZ System, Image Processing, Radiological
Xoran Technologies, Inc.
XoranConnect, software version 4.1.0.6, Xoran Technologies, Ann Arbor, MI. A web-based software which provides online multi-planar image viewing, offsite data storage, administrative reporting tools, and teleradiology workflow. Server designed to store and serve stored imaging content on a RAID5 storage device.
| Date | Jul 9, 2009 (initiated Feb 3, 2009) |
| Status | Terminated |
| Reason | An incorrect patient name label may appear on the screen displaying the selected patient's scan. |
| Root cause | Software design |
| Action | The firm released software version 4.1.0.7 by uploading it through a remote software upgrade on February 3, 2009. User accounts were notified by letter dated February 9, 2009. Direct questions to Xoran Technologies at 1-800-709-6726. |
| Quantity | 14 |
| Distribution | Nationwide Distribution (Alabama, Arizona, Colorado, Georgia, Illinois, Louisiana, New York, North Carolina, Oklahoma, Rhode Island, Tennessee, Texas and Utah). |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K073306 | XORANCONNECT Xoran Technologies, Inc., Jan 7, 2008 |