ClearanceBrief
Recall Z-0749-2007 ยท IZL System, X-Ray, Mobile

Siemens Medical Solutions USA, Inc

Mobilett XP, mobile X-ray system, Model number 1818454

DateApr 19, 2007 (initiated Mar 21, 2007)
StatusTerminated
ReasonMounting bolts for tank fork assembly and collimator flange may become loose.
Root causeOther
ActionSiemens Service Personnel are visiting each consignee, beginning March 21, 2007, to replace the required mounting bolts and tighten them according to required torque specifications.
Quantity186 units
DistributionThe products were shipped to medical facilities nationwide.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K033238MOBILETTE XP AND MOBILETT XPHYBRID
Siemens Medical Systems, Inc., Nov 14, 2003