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.
This recall has been terminated (originally issued November 27, 2007).
- Company
- Xoran Technologies, Inc.
- Recall Initiated
- July 13, 2006
- Posted
- November 27, 2007
- Terminated
- March 13, 2008
- Recall Number
- Z-0296-2008
- Quantity
- 5
- Firm Location
- Ann Arbor, MI
- Official Source
- View on FDA website ↗
Reason for Recall
The hard drive may crash, resulting in loss of data from patient CT scans.
Distribution
Nationwide Distribution: California, South Dakota, Tennessee, Utah and West Virginia.
Lot / Code Info
Serial Numbers: ENT00009, ENT00051, ENT00084, ENT00086 and ENT00088.
Root Cause
Finished device change control
Action Taken
Consignee accounts were visited between 7/25/06 and 8/10/07 and the hard drives on their systems were replaced.
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