Recall Z-0468-2015 ยท IYB Tube Mount, X-Ray, Diagnostic
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.
| Date | Dec 1, 2014 (initiated Oct 28, 2014) |
| Status | Terminated |
| 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 th |
| Quantity | 32 |
| Distribution | US Distribution including the states of: AZ, CO, IL, KY, LA, NE, NY, OH, PA, TN, TX, VA, WA and WV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K850198 | FLOOR TO WALL OR FLOOR TO CEILING TUBESTAND;RADIOG Summit Industries, Inc., May 14, 1985 |