Z-0038-2014Class II

Xoran Minicat00202

Name: Z-0038-2014 Xoran Minicat00202
Creator: Xoran Technologies, Inc.
Published: 2010-07-27
License: https://open.fda.gov/license/

Xoran Technologies, LLC / initiated 2010-07-27 / Terminated

FDA source

Xoran Technologies, Inc. began a recall of Xoran Minicat00202 on 2010-07-27. FDA classified it as Class II and gives the reason as "The MiniCAT CT Scanners subject to this notification failed to meet Xoran's specifications for dose rate of 125 3 kVp. These 18 complaints received include dose rates both on the high and low end of Xoran's...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0038-2014
Classification: Class II
Status: Terminated
Initiated: 2010-07-27
Posted: 2015-06-26
Terminated: 2014-09-11
Recalling firm: Xoran Technologies, LLC
Product: Xoran Minicat00202
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: The MiniCAT CT Scanners subject to this notification failed to meet Xoran's specifications for dose rate of 125 3 kVp. These 18 complaints received include dose rates both on the high and low end of Xoran's specifications. See ATTACHMENT 1 for details. (e) A n evaluation of the hazards reasonably related to defect or the failure to comply with the Federal standard; An evaluation of the health ha
FDA root cause: Radiation Control for Health and Safety Act
Action: All of the MiniCAT CT Scanners subject to these complaints were serviced by Xoran technicians and the out-of-specifications devices were brought into specification. This was accomplished by either readjusting the settings or by installing a new component. Xoran's Research & Development group is evaluating the current specification to see if the field specifications are appropriate and to ensure that proper testing protocols are communicated and are in place for use by 3 rd party testing organizations. In addition, Xoran has initiated CAPA # 18 0 that is looking at the source block with regard to evaluating the stability of the dose rating.
Quantity in commerce: 320
Distribution: Worldwide Distribution - US nationwide
Product codes and lots: minicat

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0038-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0038-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-06	2013-10-25
Z-0039-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-06	2013-10-25

Product code JAK

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)