ClearanceBrief
Recall Z-1080-2014 ยท IZI System, X-Ray, Angiographic

Siemens Medical Solutions USA, Inc

Siemens Artis zee Ceiling Systems. Angiographic x-ray system.

DateFeb 24, 2014 (initiated Dec 16, 2013)
StatusTerminated
ReasonDuring the lifetime of Artis zee Ceiling systems, there is an increased wear due to potential sub-optimal cable guidance that can lead to cable damage.
Root causeDevice Design
ActionIn December 2013, a recall notification letter was sent to Users.
Quantity284
DistributionNationwide Distribution.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

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