FDA Medical Device Recalls (openFDA)
Xoran Technologies, Inc.: 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.
- Recall number
- Z-0296-2008
- Recalling firm
- Xoran Technologies, Inc.
- Product
- 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.
- Status
- Terminated
- Initiated
- 2006-07-13
- Posted
- 2007-11-27
- Terminated
- 2008-03-13
- Reason
- The hard drive may crash, resulting in loss of data from patient CT scans.
- Root cause
- Finished device change control
- Action
- Consignee accounts were visited between 7/25/06 and 8/10/07 and the hard drives on their systems were replaced.
- Quantity
- 5
- Distribution
- Nationwide Distribution: California, South Dakota, Tennessee, Utah and West Virginia.
- Lot, serial or model codes
- Serial Numbers: ENT00009, ENT00051, ENT00084, ENT00086 and ENT00088.
- 510(k) numbers
- ["K032243"]
- PMA numbers
- not on file
- Product code
- JAK
- Firm FEI
- 3004198450
- Firm city
- Ann Arbor
- Firm state
- MI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28