Events

Recall of Xoran MiniCat Model 10004

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Xoran Technologies, LLC.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    69939
  • Event Risk Class
    Class 2
  • Event Number
    Z-1210-2015
  • Event Initiated Date
    2014-09-08
  • Event Date Posted
    2015-03-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-02-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132006
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, x-ray, tomography, computed - Product Code JAK
  • Reason
    Out of tolerance kvp, unexposed (black) frames, and out of tolerance dose.
  • 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.

Device

Xoran MiniCat Model 10004
  • Model / Serial
    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
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    Xoran MiniCAT X-ray imaging device
  • Manufacturer
    Xoran Technologies, LLC

Manufacturer

Xoran Technologies, LLC
  • Manufacturer Address
    Xoran Technologies, LLC, 5210 S State Rd, Ann Arbor MI 48108-7936
  • Manufacturer Parent Company (2017)
    Xoran Technologies LLC
  • Source
    USFDA