Magnetom Espree with Swiveling OR (Operating Room) Table, Magnetic Resonance Imaging System,Siemens Medical Solutions US
FDA device recall Z-0518-2008 · posted 2008-02-05 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- Table may experience a deadlock situation
- Action taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LNH
- Quantity affected
- 4 units
- Distribution
- The products were shipped to medical facilities in TX and NY.
- Date initiated
- 2007-11-05
- Date posted
- 2008-02-05
- Date terminated
- 2008-02-05
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MAGNETOM ESPREE SYSTEM (K041112) | Siemens Medical Solutions USA, Inc. | 2004-07-21 |