FDA Enforcement
Class II
Terminated
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: Z-0468-2015
·
Reported December 3, 2014
Enforcement
- Recall Number
- Z-0468-2015
- Event ID
- 69631
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Summit Industries Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 3, 2014
- Initiation Date
- October 28, 2014
- Classification Date
- November 26, 2014
- Termination Date
- May 21, 2015
- Address
- 2901 W Lawrence Ave, N/A, Chicago, IL, 60625-3621, United States
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.
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.
Code Info
Model Numbers: J700-01, J700-02, J700-03, J700-04
Distribution
US Distribution including the states of: AZ, CO, IL, KY, LA, NE, NY, OH, PA, TN, TX, VA, WA and WV.
Quantity
32