Events

Recall of Dunlee DA 200 PRO & MX 200 PRO CT XRay Tube Housing Assembly

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

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
    31457
  • Event Risk Class
    Class 2
  • Event Number
    Z-0839-05
  • Event Initiated Date
    2005-04-07
  • Event Date Posted
    2005-05-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-10-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=38781
  • 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
    Assembly, Tube Housing, X-Ray, Diagnostic - Product Code ITY
  • Reason
    The x-ray tube housing assembly may have been mounted with the incorrect sized bolts.
  • Action
    Dunlee sent recall letters dated 4/4/05 to end user locations, informing them that Dunlee and their service representatives would visit each location to replace the mounting bolts on all Dunlee DA-200 Performix installations because of problems experienced at certain GE CT installations. Any questions were directed to John M. Macko, Product Marketing Manager, at 630-585-2174.

Device

Dunlee DA 200 PRO & MX 200 PRO CT XRay Tube Housing Assembly
  • Model / Serial
    Model DA 200 PRO and MX200 PRO, part number 884-01, serial (anode) numbers 17549, 18997, 21821, 23112
  • Product Classification
    Radiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide and internationally to Taiwan, Germany and Mexico.
  • Product Description
    Dunlee DA 200 PRO & MX 200 PRO CT X-Ray Tube Housing Assembly (989600088401); replacement x-ray tube housing assemblies; Dunlee, 555 North Commerce Street, Aurora, Illinois 60504 U.S.A.; part number 875-01
  • Manufacturer
    Dunlee

Manufacturer

Dunlee
  • Manufacturer Address
    Dunlee, 555 Commerce St, Aurora IL 60504-8110
  • Source
    USFDA