Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0518-2008

Magnetom Espree with Swiveling OR (Operating Room) Table, Magnetic Resonance Imaging System,Siemens Medical...

Siemens Medical Solutions USA, Inc. / initiated 2007-11-05 / Terminated / root cause: software

Siemens Medical Solutions USA, Inc began a recall of Magnetom Espree with Swiveling OR (Operating Room) Table, Magnetic Resonance Imaging System,Siemens Medical Solutions USA, Inc., Malvern, PA on . The reason FDA records is "Table may experience a deadlock situation". As of , the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number
Z-0518-2008
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Siemens Medical Solutions USA, Inc.
Product
Magnetom Espree with Swiveling OR (Operating Room) Table, Magnetic Resonance Imaging System,Siemens Medical Solutions USA, Inc., Malvern, PA
Product code
LNH System, Nuclear Magnetic Resonance Imaging
Reason for recall
Table may experience a deadlock situation
Root cause tag
software
FDA root cause
Software design
Action
The recalling firm issued a Customer Safety Advisory to affected customers per Update Instructions MR031/07/S. The letter informs customers of the potential issue and provides instructions to avoid its occurrence. The recalling firm has also released the software update to correct the issue via Update Instructions MR034/07/S. Notifications were issued on or about November 5, 2007.
Quantity in commerce
4 units
Distribution
The products were shipped to medical facilities in TX and NY.
Product codes and lots
Serial Numbers 1002, 1003, 1004, and 1007