Events

Recall of Device Recall Minicat CT Scanner

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

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
    66337
  • Event Risk Class
    Class 2
  • Event Number
    Z-0037-2014
  • Event Initiated Date
    2010-07-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-09-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122076
  • 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
    A description of the defect in the product or the manner in which the product fails to comply wvith an applicable federal standard; 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 evalu.
  • 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.

Device

Device Recall Minicat CT Scanner
  • Model / Serial
    Minicat
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - Nationwide
  • Product Description
    Xoran MiniCAT CT Scanner
  • Manufacturer
    Xoran Technologies, Inc.

Manufacturer

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