Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1529-05

Magnetom Espree. Magnetic Resonance Imaging System. model number 10018165

Siemens Medical Solutions USA, Inc. / initiated 2005-08-12 / Terminated

Siemens Medical Solutions USA, Inc began a recall of Magnetom Espree. Magnetic Resonance Imaging System. model number 10018165 on . The reason FDA records is "there is a misalignment of the patient table that may occur between the patient table and the opening to the magnet bore". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-1529-05
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Siemens Medical Solutions USA, Inc.
Product
Magnetom Espree. Magnetic Resonance Imaging System. model number 10018165
Product code
LNN
Reason for recall
there is a misalignment of the patient table that may occur between the patient table and the opening to the magnet bore
FDA root cause
Other
Action
The recalling firm issued via certified mail a Customer Safety Advisory to the affected customers per Update Instructions MR031/05/S. the letter informs customers of the potential issue and provides instructions to avoid its occurrence.
Quantity in commerce
209 units
Distribution
The products were shipped to medical facilities and MRI facilities nationwide.
Product codes and lots
Serial numbers 30001 to 30075