ClearanceBrief
Recall Z-0974-04 ยท IYB Tube Mount, X-Ray, Diagnostic

Fischer Imaging Corporation

VersaRad/Traumex General Radiographic System.

DateJul 20, 2004 (initiated Apr 23, 2004)
StatusTerminated
ReasonIf 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 causeOther
ActionConsignees were notified by letter on 4/23/2004.
Quantity138 units
DistributionNationwide, 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 recordOpen on fda.gov

510(k) clearances named in this recall

K880530CEILING MOUNTED RADIOGRAPHIC SYSTEM TRAUMEX
Fischer Imaging Corp., Mar 3, 1988