ClearanceBrief
Recall Z-0989-05 ยท KPR System, X-Ray, Stationary

Siemens Medical Solutions USA, Inc

Axiom Aristos MX/VX. Model number 58 95 003

DateJul 13, 2005 (initiated Jun 10, 2005)
StatusTerminated
Reasonpotential issue (system may lock up) when repeating patient registrations
Root causeOther
ActionThe recalling firm issed a Customer Advisory Letter via certified mail to their cutomers informing them of the problem and information for the workaround to prevent problems for occurring until the software is upgraded.
Quantity72 units
DistributionNationwide. The products were shipped to hospitals in AZ, CA, CO, FL, GA, IL, IN, KS, KY, ME, MI, MO, NC, NE, NJ, NY, OK, PA, TN, TX, UT, VA, WA, and WI.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K013826AXIOM ARISTOS FX (MULTI PURPOSE RADIOGRAPHY SYSTEM)
Siemens Medical Systems, Inc., Feb 1, 2002