ClearanceBrief
Recall Z-0493-03 ยท IXR Table, Radiographic, Tilting

Siemens Medical Systems Inc

Uroskop D1/D2/D3 - Table, Radiographic, Stationary Top.

DateJan 30, 2003 (initiated Nov 27, 2002)
StatusTerminated
ReasonThere is unintended system movement or unwanted automatic movement of the tabletop.
Root causeOther
ActionSiemens personal will install Host Software VA00F and Generator Host Software VE00D on affected Uroskop units. Update instructions were sent to users November 27,2002 and December 7, 2002.
Quantity13
DistributionProduct was distributed to 6 hospitals nationwide and 5 government hospitals. Internationally, the tables were distributed to Germany, Netherlands, Italy , Luxembourg, Sweden, Austria, Switzerland, Slovakia, Hungary, Ukraine, Russia, Turkmenistan, South Africa, Canada, Malaysia, Japan, and Taiwan.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K923049UROSKOP D1, UROSKOP D2, AND UROSKOP D3
Siemens Medical Solutions USA, Inc., Sep 15, 1992