Z-1210-2015Class II

Xoran MiniCAT X-ray imaging device

Name: Z-1210-2015 Xoran MiniCAT X-ray imaging device
Creator: Xoran Technologies, LLC
Published: 2014-09-08
License: https://open.fda.gov/license/

Xoran Technologies, LLC / initiated 2014-09-08 / Terminated

FDA source

Xoran Technologies, LLC began a recall of Xoran MiniCAT X-ray imaging device on 2014-09-08. FDA classified it as Class II and gives the reason as "Out of tolerance kVp, Unexposed (black) frames, and Out of tolerance Dose". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1210-2015
Classification: Class II
Status: Terminated
Initiated: 2014-09-08
Posted: 2015-03-02
Terminated: 2016-02-02
Recalling firm: Xoran Technologies, LLC
Product: Xoran MiniCAT X-ray imaging device
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: Out of tolerance kVp, Unexposed (black) frames, and Out of tolerance Dose.
FDA root cause: Radiation Control for Health and Safety Act
Action: Xoran Planned Action : A Xoran Technologies service representative will re-measure and perform calibration to correct all affected systems for kVp and dose issues. For the image quality issue, the service representative will mark the black frame and then attempt to reconstruct an adequate image. CDRH also understands that you are continuing your investigation to determine the root cause and a more permanent corrective action for the 3 identified defects. 1. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. 2. A customer notification letter which includes a statement that Xoran Technologies, LLC will without charge, remedy the defect or bring the product into compliance. 3. Xoran Technologies, LLC will continue to evaluate why the kVp is not always within Xoran specifications, why the unexposed frames continues to occur, and why the dose is not always within Xoran specifications and identify the actions needed to resolve these issues by July 1, 2015. Xoran will communicate the results of this evaluation and any necessary actions to both customers and CDRH. Further questions please call (734) 663-7194.
Quantity in commerce: 432
Distribution: Nationwide Distribution
Product codes and lots: S/N ENT00031 MiniCAT0020 MiniCAT00361 MiniCAT00358 MiniCAT00150 MiniCAT00310 ENT00006 ENT00055 ENT00059 MiniCAT00140 MiniCAT00305 ENT00014 MiniCAT00148 ENT00039 ENT00076 MiniCAT00409 MiniCAT00179 ENT00014 MiniCAT00215 MiniCAT00309 ENT00035 MiniCAT00158 MiniCAT00386 MiniCAT00202 MiniCAT00324 ENT00127 MiniCAT00352 MiniCAT00396 MiniCAT00194 ENT00080 MiniCAT00171 MiniCAT00244

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1210-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1210-2015	Class II	Terminated	Voluntary: Firm initiated	2015-03-11	2015-03-02

Product code JAK

K113421Class IIMinicatXoran Technologies, Inc. / cleared 2012-07-11

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)