Events

Recall of Xoran MiniCAT System 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
    47370
  • Event Risk Class
    Class 2
  • Event Number
    Z-0561-2010
  • Event Initiated Date
    2008-09-17
  • Event Date Posted
    2009-12-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-12-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=69359
  • 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
    Computed Tomography X-Ray System - Product Code JAK
  • Reason
    The system may overheat, causing poor image quality, interruption in image acquisition and/or damage to the system. also, if the system is not allowed to cycle down prior to being restarted after an emergency stop, the x-ray and gantry motions will both resume.
  • Action
    A letter dated 9/17/08 was sent to each account telling them that the PLC would be upgraded. The firm visited each account and made corrections.

Device

Xoran MiniCAT System for ENT
  • Model / Serial
    All units.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    Xoran MiniCAT System for ENT (server and work station), Xoran Technologies, Ann Arbor, MI. || Cone beam CT for sinus, 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