Z-0826-2008

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

Name: Z-0826-2008 Xoran MiniCAT System for ENT (server and work station), Xoran Technologies, Ann Arbor, MI
Creator: Xoran Technologies, Inc.
Published: 2008-01-04
License: https://open.fda.gov/license/

Xoran Technologies, LLC / initiated 2008-01-04 / Terminated / root cause: labeling and UDI

FDA source

Xoran Technologies, Inc. began a recall of Xoran MiniCAT System for ENT (server and work station), Xoran Technologies, Ann Arbor, MI on 2008-01-04. The reason FDA records is "Misbranding; These devices do not bear the manufacturer's name or address". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0826-2008
Status: Terminated
Initiated: 2008-01-04
Posted: 2008-02-07
Terminated: 2010-10-22
Recalling firm: Xoran Technologies, LLC
Product: Xoran MiniCAT System for ENT (server and work station), Xoran Technologies, Ann Arbor, MI
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: Misbranding; These devices do not bear the manufacturer's name or address.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: Consignees were notified via letter, Urgent Medical Device Correction, dated 1/4/08 of the need to apply proper labeling to the products, and were sent instructions and labeling to affix to their units.
Quantity in commerce: 71
Distribution: Nationwide.
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)