Z-0041-2014Class II

Xoran MiniCAT CT Scanner ID ENT00001

Name: Z-0041-2014 Xoran MiniCAT CT Scanner ID ENT00001
Creator: Xoran Technologies, Inc.
Published: 2009-12-14
License: https://open.fda.gov/license/

Xoran Technologies, LLC / initiated 2009-12-14 / Terminated

FDA source

Xoran Technologies, Inc. began a recall of Xoran MiniCAT CT Scanner ID ENT00001 on 2009-12-14. FDA classified it as Class II and gives the reason as "Failure of the gantry to rotate. The complaint alleged that the scanner would emit radiation but would not rotate". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0041-2014
Classification: Class II
Status: Terminated
Initiated: 2009-12-14
Posted: 2015-06-26
Terminated: 2014-09-11
Recalling firm: Xoran Technologies, LLC
Product: Xoran MiniCAT CT Scanner ID ENT00001
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: Failure of the gantry to rotate. The complaint alleged that the scanner would emit radiation but would not rotate.
FDA root cause: Radiation Control for Health and Safety Act
Action: The service report in response to this complaint stated that the Head select relay board, chip and fan were replaced. The machine (ENTOOOO I) was subsequently tested. All tests were successful.
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-0041-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0041-2014	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)