Device 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.
Z-0468-2015
Product summary
- Event
- Event 69631
- Status
- Terminated
- Classification
- Class II
- Quantity
- 32
- Official record key
device-enforcement:Z-0468-2015
Official wording
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 information: Model Numbers: J700-01, J700-02, J700-03, J700-04
Distribution pattern: US Distribution including the states of: AZ, CO, IL, KY, LA, NE, NY, OH, PA, TN, TX, VA, WA and WV.
Derived failure modes
-
Unknown
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.