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U.S. Department of Health and Human Services

Class 2 Device Recall Summit Industries Floor Mounted Tubestand

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  Class 2 Device Recall Summit Industries Floor Mounted Tubestand see related information
Date Initiated by Firm October 28, 2014
Date Posted December 01, 2014
Recall Status1 Terminated 3 on May 21, 2015
Recall Number Z-0468-2015
Recall Event ID 69631
510(K)Number K850198  
Product Classification Tube mount, x-ray, diagnostic - Product Code IYB
Product 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.
Code Information Model Numbers: J700-01, J700-02, J700-03, J700-04
Recalling Firm/
Manufacturer		 Summit Industries Inc.
2901 W Lawrence Ave
Chicago IL 60625-3621
For Additional Information Contact Mr. William J. Engel
773-353-4030
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Process control
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.
Quantity in Commerce 32
Distribution US Distribution including the states of: AZ, CO, IL, KY, LA, NE, NY, OH, PA, TN, TX, VA, WA and WV.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = IYB and Original Applicant = SUMMIT INDUSTRIES, INC.
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