Recall Z-0974-04 ยท IYB Tube Mount, X-Ray, Diagnostic
Fischer Imaging Corporation
VersaRad/Traumex General Radiographic System.
| Date | Jul 20, 2004 (initiated Apr 23, 2004) |
| Status | Terminated |
| Reason | If two of the four T-nuts that connect the transverse rail to the ceiling rail fail, the 'U' arm and transverse rails could fall and cause serious injury. |
| Root cause | Other |
| Action | Consignees were notified by letter on 4/23/2004. |
| Quantity | 138 units |
| Distribution | Nationwide, including VA facilities in MI, MN and VT. No military consignees. Foreign distribution to Australia, Canada, Denmark, Italy, Korea, Netherlands, Norway, Sweden, United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K880530 | CEILING MOUNTED RADIOGRAPHIC SYSTEM TRAUMEX Fischer Imaging Corp., Mar 3, 1988 |