Recall Z-0561-2010 ยท JAK System, X-Ray, Tomography, Computed
Xoran Technologies, Inc.
Xoran MiniCAT System for ENT (server and work station), Xoran Technologies, Ann Arbor, MI. Cone beam CT for sinus, temporal bones, and maxillofacial imaging.
| Date | Dec 23, 2009 (initiated Sep 17, 2008) |
| Status | Terminated |
| Reason | The system may overheat, causing poor image quality, interruption in image acquisition and/or damage to the system. Also, if the system is not allowed to cycle down prior to being restarted after an emergency stop, the x-ray and gantry motions will both resume. |
| Root cause | Device Design |
| Action | A letter dated 9/17/08 was sent to each account telling them that the PLC would be upgraded. The firm visited each account and made corrections. |
| Quantity | 82 |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032243 | MINICAT DENTOCAT Xoran Technologies, Inc., Oct 2, 2003 |