Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1205-06

3D-I/III Ceiling Stand. Diagnostic x-ray tube mount

Siemens Medical Solutions USA, Inc. / initiated 2006-04-28 / Terminated

Siemens Medical Solutions USA, Inc began a recall of 3D-I/III Ceiling Stand. Diagnostic x-ray tube mount on . The reason FDA records is "Firm became aware that a potential pinch point can exist between the stop level and the safety catch when rotating the x-ray tube assembly. Risk of injury to operators fingers". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-1205-06
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Siemens Medical Solutions USA, Inc.
Product
3D-I/III Ceiling Stand. Diagnostic x-ray tube mount
Product code
IYB Tube Mount, X-Ray, Diagnostic
Reason for recall
Firm became aware that a potential pinch point can exist between the stop level and the safety catch when rotating the x-ray tube assembly. Risk of injury to operators fingers.
FDA root cause
Other
Action
The recalling firm has issued a field correction per Update Instructions AX012/06/S. This update instructs a Siemens Customer Service Engineer to visit affected consignees to install a protective cover and additional warning labels on the device, beginning 04/28/2006.
Quantity in commerce
466 units
Distribution
The products were shipped nationwide to medical facilities.
Product codes and lots
Model numbers 0923/G0923, 1022, 1080, 1212687, 1371970, 1372325, 1654250, 1576164, 8186751, 7388002, 7389489, 1738509, 1738517, 1738525, 7276504, 7276512, 7276520, 7276553, 7465008, 7486822, and 8185530.