Z-0296-2008

Xoran MiniCAT for ENT, Xoran Technologies, Incorporated, Ann Arbor, MI 48103. This device is a cone beam CT...

Name: Z-0296-2008 Xoran MiniCAT for ENT, Xoran Technologies, Incorporated, Ann Arbor, MI 48103. This device is a cone beam CT...
Creator: Xoran Technologies, Inc.
Published: 2006-07-13
License: https://open.fda.gov/license/

Xoran Technologies, LLC / initiated 2006-07-13 / Terminated

FDA source

Xoran Technologies, Inc. began a recall of 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... on 2006-07-13. The reason FDA records is "The hard drive may crash, resulting in loss of data from patient CT scans". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0296-2008
Status: Terminated
Initiated: 2006-07-13
Posted: 2007-11-27
Terminated: 2008-03-13
Recalling firm: Xoran Technologies, LLC
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.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: The hard drive may crash, resulting in loss of data from patient CT scans.
FDA 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 in commerce: 5
Distribution: Nationwide Distribution: California, South Dakota, Tennessee, Utah and West Virginia.
Product codes and lots: Serial Numbers: ENT00009, ENT00051, ENT00084, ENT00086 and ENT00088.

Product code JAK

K032243Class IIMinicat DentocatXoran Technologies, Inc. / cleared 2003-10-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)