ClearanceBrief
Recall Z-0143-2009 ยท IZI System, X-Ray, Angiographic

Siemens Medical Solutions USA, Inc

BICOR HS X-Ray System, Model number 6005776

DateNov 4, 2008 (initiated Aug 11, 2008)
StatusTerminated
ReasonUnintended movement of the system table and/or C arm.
Root causeSoftware design
ActionSiemens Medical Solutions issued a letter to consignees on 8/11/2008 to inform them of the problem and a workaround should the issue occur prior to software revision.
Quantity2 UNITS
DistributionNationwide.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K940484COROSKOP HI-P ANGIOGRAPHIC X-RAY SYSTEM
Siemens Medical Solutions USA, Inc., Apr 19, 1994