Recall Z-0826-2008 ยท JAK System, X-Ray, Tomography, Computed
Xoran Technologies, Inc.
Xoran MiniCAT System for ENT (server and work station), Xoran Technologies, Ann Arbor, MI
| Date | Feb 7, 2008 (initiated Jan 4, 2008) |
| Status | Terminated |
| Reason | Misbranding; These devices do not bear the manufacturer's name or address. |
| Root cause | Labeling design |
| Action | Consignees were notified via letter, Urgent Medical Device Correction, dated 1/4/08 of the need to apply proper labeling to the products, and were sent instructions and labeling to affix to their units. |
| Quantity | 71 |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032243 | MINICAT DENTOCAT Xoran Technologies, Inc., Oct 2, 2003 |