ClearanceBrief
Recall Z-1032-03 ยท IZI System, X-Ray, Angiographic

Siemens Medical Solutions USA, Inc

Cathcor/LX/Desktop, System, X-Ray, Angiographic

DateJul 19, 2003 (initiated Nov 27, 2002)
StatusTerminated
ReasonIncorrect CTR values are found when used with ODBC interface, and may result in misdiagnosis.
Root causeOther
ActionA Customer Safety Advisory Letter was sent via registered mail on 10/30/2002.
Quantity9
Distribution5 Hospitals/Clinics in the US.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K002137CATHCOR DESKTOP
Siemens Elema AB, Oct 5, 2000