Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0335-06

3D TOP Ceiling Stand. X-Ray System model number 8773673

Siemens Medical Solutions USA, Inc. / initiated 2005-11-30 / Terminated

Siemens Medical Solutions USA, Inc began a recall of 3D TOP Ceiling Stand. X-Ray System model number 8773673 on . The reason FDA records is "screws on the rollers may become loose". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0335-06
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Siemens Medical Solutions USA, Inc.
Product
3D TOP Ceiling Stand. X-Ray System model number 8773673
Product code
IYB Tube Mount, X-Ray, Diagnostic
Reason for recall
screws on the rollers may become loose
FDA root cause
Other
Action
The recalling firm has issued a field correction per Update Instructions AX004/06/S. This update instructs a Siemens Customer Service Engineer to visit affected consignees and checkthe screws on the rollers. It also provides roller bearing sleeves as a secondary safety mechanism to prevent the rollers from detaching.
Quantity in commerce
460 units
Distribution
The products were shipped to hospitals and medical facilities nationwide.
Product codes and lots
Model number 8773673