Events

Recall of Device Recall Xoran MiniCAT for ENT.

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
    45529
  • Event Risk Class
    Class 2
  • Event Number
    Z-0296-2008
  • Event Initiated Date
    2006-07-13
  • Event Date Posted
    2007-11-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-03-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=65740
  • 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
    CT Scan - Product Code JAK
  • Reason
    The hard drive may crash, resulting in loss of data from patient ct scans.
  • Action
    Consignee accounts were visited between 7/25/06 and 8/10/07 and the hard drives on their systems were replaced.

Device

Device Recall Xoran MiniCAT for ENT.
  • Model / Serial
    Serial Numbers: ENT00009, ENT00051, ENT00084, ENT00086 and ENT00088.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution: California, South Dakota, Tennessee, Utah and West Virginia.
  • Product Description
    Xoran MiniCAT for ENT, Xoran Technologies, Incorporated, Ann Arbor, MI 48103. This device is a cone beam CT scan for sinue, temporal bones and maxillofacial imaging.
  • Manufacturer
    Xoran Technologies, Inc.

Manufacturer

Xoran Technologies, Inc.
  • Manufacturer Address
    Xoran Technologies, Inc., 309 N 1st St, Ann Arbor MI 48103-3301
  • Source
    USFDA