FDAFDA · Food and drugs·Recall number Z-0468-2015
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.
Published December 3, 2014 · Recall initiated: October 28, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Summit Industries Inc.
- Distributor
- US Distribution including the states of: AZ, CO, IL, KY, LA, NE, NY, OH, PA, TN, TX, VA, WA and WV.
- Lot
- Model Numbers: J700-01, J700-02, J700-03, J700-04
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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