Xoran MiniCAT System for ENT (server and work station), Xoran Technologies, Ann Arbor, MI. Cone beam CT for sinus, tempo
FDA device recall Z-0561-2010 · posted 2009-12-23 · Terminated
Recall details
- Recalling firm
- Xoran Technologies, Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 82
- Distribution
- Nationwide Distribution
- Date initiated
- 2008-09-17
- Date posted
- 2009-12-23
- Date terminated
- 2009-12-23
- Location
- Ann Arbor, MI
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MINICAT DENTOCAT (K032243) | Xoran Technologies, Inc. | 2003-10-02 |