Z-0468-2015Class II

The J700 Floor Mounted Tube Stand (FMTS) is intended to support and position the diagnostic x-ray tube...

Name: Z-0468-2015 The J700 Floor Mounted Tube Stand (FMTS) is intended to support and position the diagnostic x-ray tube...
Creator: Summit Industries Inc.
Published: 2014-10-28
License: https://open.fda.gov/license/

Summit Industries, LLC / initiated 2014-10-28 / Terminated / root cause: manufacturing process

FDA source

Summit Industries Inc. began a recall of 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... on 2014-10-28. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0468-2015
Classification: Class II
Status: Terminated
Initiated: 2014-10-28
Posted: 2014-12-01
Terminated: 2015-05-21
Recalling firm: Summit Industries, LLC
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.
Product code: IYB Tube Mount, X-Ray, Diagnostic
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.
Root cause tag: manufacturing process
FDA root cause: 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.
Product codes and lots: Model Numbers: J700-01, J700-02, J700-03, J700-04

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0468-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0468-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-03	2014-11-26

Product code IYB

K850198Class IFloor to Wall or Floor to Ceiling Tubestand;radiogSummit Industries, Inc. / cleared 1985-05-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)