ClearanceBrief
Recall Z-1213-2010 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified

Siemens Medical Solutions USA, Inc

Axiom Iconos R200 X-Ray

DateMar 27, 2010 (initiated Jan 29, 2010)
StatusTerminated
Reasontable can tilt/move when it is not intended
Root causeSoftware design
ActionThe recalling firm has issued a letter to affected customers and will send technicians to apply the fix to each defective device.
Quantity169 units
DistributionNationwide Distribution.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K992660URF DIGITAL - OT
Siemens Medical Solutions USA, Inc., Nov 5, 1999