Siemens Magentom Symphony syngo Upgrade, Model Number: 7106557, Siemens Medical Solutions USA, Malvern PA, 19355
FDA device recall Z-1048-2008 · posted 2008-03-25 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- Magnet Quench, unintended- magnet of a mobile MRI system quenched into the exam room.
- Action taken
- The firm issued an Update Instruction package to consignees 12/07. As an immediate measure, the recalling firm is initiating field checks of mobile MRI systems per Update Instruction MR039/07/S. This update defines a safety inspection for mobile systems, including checks for potential ice formation and proper configuration of venting assemblies.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- LNH
- Quantity affected
- 35 units
- Distribution
- Nationwide Distribution
- Date initiated
- 2007-12-01
- Date posted
- 2008-03-25
- Date terminated
- 2012-10-01
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MAGNETOM PROJECT 024 SYSTEM (NUMARIS 3.5 SOFTWARE) (K970852) | Siemens Medical Solutions USA, Inc. | 1997-06-05 |