Recall Z-0296-2008 ยท JAK System, X-Ray, Tomography, Computed
Xoran Technologies, Inc.
Xoran MiniCAT for ENT, Xoran Technologies, Incorporated, Ann Arbor, MI 48103. This device is a cone beam CT scan for sinue, temporal bones and maxillofacial imaging.
| Date | Nov 27, 2007 (initiated Jul 13, 2006) |
| Status | Terminated |
| Reason | The hard drive may crash, resulting in loss of data from patient CT scans. |
| Root cause | Finished device change control |
| Action | Consignee accounts were visited between 7/25/06 and 8/10/07 and the hard drives on their systems were replaced. |
| Quantity | 5 |
| Distribution | Nationwide Distribution: California, South Dakota, Tennessee, Utah and West Virginia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032243 | MINICAT DENTOCAT Xoran Technologies, Inc., Oct 2, 2003 |