Z-0561-2010

Xoran MiniCAT System for ENT (server and work station), Xoran Technologies, Ann Arbor, MI. Cone beam CT for...

Name: Z-0561-2010 Xoran MiniCAT System for ENT (server and work station), Xoran Technologies, Ann Arbor, MI. Cone beam CT for...
Creator: Xoran Technologies, Inc.
Published: 2008-09-17
License: https://open.fda.gov/license/

Xoran Technologies, LLC / initiated 2008-09-17 / Terminated / root cause: design

FDA source

Xoran Technologies, Inc. began a recall of Xoran MiniCAT System for ENT (server and work station), Xoran Technologies, Ann Arbor, MI. Cone beam CT for sinus, temporal bones, and maxillofacial imaging on 2008-09-17. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0561-2010
Status: Terminated
Initiated: 2008-09-17
Posted: 2009-12-23
Terminated: 2009-12-23
Recalling firm: Xoran Technologies, LLC
Product: Xoran MiniCAT System for ENT (server and work station), Xoran Technologies, Ann Arbor, MI. Cone beam CT for sinus, temporal bones, and maxillofacial imaging.
Product code: JAK System, X-Ray, Tomography, Computed
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.
Root cause tag: design
FDA root cause: Device Design
Action: 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.
Quantity in commerce: 82
Distribution: Nationwide Distribution
Product codes and lots: All units.

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)