ClearanceBrief
Recall Z-1205-06 ยท IYB Tube Mount, X-Ray, Diagnostic

Siemens Medical Solutions USA, Inc

3D-I/III Ceiling Stand. Diagnostic x-ray tube mount

DateJul 6, 2006 (initiated Apr 28, 2006)
StatusTerminated
ReasonFirm became aware that a potential pinch point can exist between the stop level and the safety catch when rotating the x-ray tube assembly. Risk of injury to operators fingers.
Root causeOther
ActionThe recalling firm has issued a field correction per Update Instructions AX012/06/S. This update instructs a Siemens Customer Service Engineer to visit affected consignees to install a protective cover and additional warning labels on the device, beginning 04/28/2006.
Quantity466 units
DistributionThe products were shipped nationwide to medical facilities.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.