ClearanceBrief
Recall Z-0171-2011 ยท IZL System, X-Ray, Mobile

Siemens Medical Solutions USA, Inc

Mobilett XP and Mobilett XP Hybrid, Mobile radiology device System, x-ray, mobile

DateNov 1, 2010 (initiated Oct 4, 2010)
StatusTerminated
ReasonUnits not equipped with protective plastic cover over electronics.
Root causeDevice Design
ActionSiemens Medical Solutions USA, Inc issued a mandatory field update. The letter identified the product, the problem and the action to be taken by the customer. All systems that were not yet equipped with protective cover over the D972 board would be upgraded. For questions regarding this recall call (610) 448-3237.
Quantity177 units
DistributionNationwide Distribution including AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, LA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OK, PA, TX, VA, WA, WI, WY AND PUERTO RICO.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

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