FDA Device

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.

Hazard

The hard drive may crash, resulting in loss of data from patient CT scans.

What You Should Do

Remedy

Consignee accounts were visited between 7/25/06 and 8/10/07 and the hard drives on their systems were replaced.

Products

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.
Brand
Xoran Technologies, Inc.
UPC
Serial Numbers: ENT00009, ENT00051, ENT00084, ENT00086 and ENT00088.

Units Affected

5