ClearanceBrief
Recall Z-1309-2014 ยท IZI System, X-Ray, Angiographic

Siemens Medical Solutions USA, Inc

Artis Zee Angiographic x-ray systems.

DateMar 31, 2014 (initiated Feb 7, 2014)
StatusTerminated
ReasonAn inappropriate cable connection was assembled for certain Artis zee systems. which may cause a system failure and possibly lead to a restricted maneuverability of the gantry system.
Root causeDevice Design
ActionA recall notification letter dated February 7, 2014, was sent to End Users.
Quantity9
DistributionMN, WI, PA, MI, AL, OH, NC, AR, and NJ.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K073290ARTIS ZEE AND ZEEGO
Siemens Medical Solutions USA, Inc., Feb 11, 2008