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
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