Z-0468-2015 Class II Terminated
FDA device recall Z-0468-2015 was initiated by Summit Industries Inc. on October 28, 2014 and is designated Class II. 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. The recall status is terminated (terminated May 21, 2015). Affected quantity: 32.
Recall Details
- Product Type
- Devices
- Report Date
- December 3, 2014
- Initiation Date
- October 28, 2014
- Termination Date
- May 21, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 32
Product 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 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.
Distribution Pattern
US Distribution including the states of: AZ, CO, IL, KY, LA, NE, NY, OH, PA, TN, TX, VA, WA and WV.
Code Information
Model Numbers: J700-01, J700-02, J700-03, J700-04