Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0493-03

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

Siemens Medical Solutions USA, Inc. / initiated 2002-11-27 / Terminated

Siemens Medical Systems Inc began a recall of Uroskop D1/D2/D3 - Table, Radiographic, Stationary Top on . The reason FDA records is "There is unintended system movement or unwanted automatic movement of the tabletop". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0493-03
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Siemens Medical Solutions USA, Inc.
Product
Uroskop D1/D2/D3 - Table, Radiographic, Stationary Top.
Product code
IXR Table, Radiographic, Tilting
Reason for recall
There is unintended system movement or unwanted automatic movement of the tabletop.
FDA root cause
Other
Action
Siemens 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.
Quantity in commerce
13
Distribution
Product 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.
Product codes and lots
Uroskop D1 -- Model #9785023 Uroskop D2/D3 -- Model #9785015