FDA Medical Device Recalls (openFDA)
Summit Industries Inc.: 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.
- Recall number
- Z-0468-2015
- Recalling firm
- Summit Industries Inc.
- 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.
- Status
- Terminated
- Initiated
- 2014-10-28
- Posted
- 2014-12-01
- Terminated
- 2015-05-21
- 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.
- 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
- 32
- Distribution
- US Distribution including the states of: AZ, CO, IL, KY, LA, NE, NY, OH, PA, TN, TX, VA, WA and WV.
- Lot, serial or model codes
- Model Numbers: J700-01, J700-02, J700-03, J700-04
- 510(k) numbers
- ["K850198"]
- PMA numbers
- not on file
- Product code
- IYB
- Firm FEI
- 1450503
- Firm city
- Chicago
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28