Xoran MiniCAT System for ENT (server and work station), Xoran Technologies, Ann Arbor, MI. Cone beam CT for sinus, temporal bones, and maxillofacial imaging.
This recall has been terminated (originally issued December 23, 2009).
- Company
- Xoran Technologies, Inc.
- Recall Initiated
- September 17, 2008
- Posted
- December 23, 2009
- Terminated
- December 23, 2009
- Recall Number
- Z-0561-2010
- Quantity
- 82
- Firm Location
- Ann Arbor, MI
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide Distribution
Lot / Code Info
All units.
Root Cause
Device Design
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.
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