Events

Recall of Summit Industries Floor Mounted Tubestand

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Summit Industries 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
    69631
  • Event Risk Class
    Class 2
  • Event Number
    Z-0468-2015
  • Event Initiated Date
    2014-10-28
  • Event Date Posted
    2014-12-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-05-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131205
  • 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
    Tube mount, x-ray, diagnostic - Product Code IYB
  • Reason
    The welds on j700 tube stands may be insufficient resulting in tube stand breakage, damage to the x-ray machine, and/or patient or healthcare provider injury.
  • Action
    Summit Industries sent an Urgent Medical Device Recall letter dated October 27, 2014, to all direct accounts (distributors). The letters included instructions for distributors to: 1) make every effort to locate the affected devices; 2) replace and return the defective parts; 3) contact the end user for any defective device(s) that were installed and determine if the affected device(s) is/are in service; 4) if the device(s) is/are still in service, deliver a copy of the "End User Letter", immobilize the tube arm, and place the REMOVE FROM SERVICE sticker on the device; 5) complete and return the attached questionnaire for a no-charge purchase order for the necessary replacement parts; and, 5) inform the end user that new replacement pats will be installed as soon as possible. Distributors with questions can contact Summit Industries at 800-729-9729 (Monday - Friday, 7:00 AM - 3:45 PM CST). The Urgent Medical Device Recall letter dated October 27, 2014, to end users advised them of the recall and the steps that Summit Industries and their distributor would be taking to correct the issue.

Device

Summit Industries Floor Mounted Tubestand
  • Model / Serial
    Model Numbers: J700-01, J700-02, J700-03, J700-04
  • Product Classification
    Radiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Distribution including the states of: AZ, CO, IL, KY, LA, NE, NY, OH, PA, TN, TX, VA, WA and WV.
  • Product Description
    The J700 Floor Mounted Tube Stand (FMTS) is intended to support and position the diagnostic x-ray tube housing assembly for a medical radiographic procedure. The product consists of a vertical column (with counterbalanced vertical carriage, counterweight and pulley system), horizontal floor car and a floor mounted track to ride on.
  • Manufacturer
    Summit Industries Inc.

Manufacturer

Summit Industries Inc.
  • Manufacturer Address
    Summit Industries Inc., 2901 W Lawrence Ave, Chicago IL 60625-3621
  • Source
    USFDA