Recalls / —
—#67977
Product
Siemens Magnetom Symphony syngo, Model Number: 7104594, Siemens Medical Solutions USA, Malvern PA, 19355
- FDA product code
- LNH — System, Nuclear Magnetic Resonance Imaging
- Device class
- Class 2
- Medical specialty
- Radiology
- 510(k) numbers
- K970852
- Affected lot / code info
- Serial Numbers: 22021, 22024, 22060, 22074, 22079, 22108, 22115, 22116, 22121, 22127, 22172, 22196, 22225, 22242, 22272, 22306, 22311, 22342, 22352, 22353, 22356, 22402, 22440, 22441, 22446, 22471, 22498, 22510, 22520, 22523, 22530, 22561, 22565, 22596, 22598, 22604, 22619, 22621 22622, 22636, 22674, 22690, 22698, 22711, 22801, 22810, 22825, 22835, 22836, 22865, 22881, 22885, 22907, 22911, 22914, 22916, 22944, 22967, 23001, 23057, 23059, 23085, 23099, 23104, 23132, 23136, 23156, 23176, 23199, 23218, 23247, 23252, 23255, 23284, 23315, 23323, 23357, 23381, 23491, 23497, 23507, 23538, 23552, 23574, 23578, 23579, 23580, 23585, 23590, 23594, 23596, 23602, 23604, 23605, 23610, 23613, 23628, 23641, 23642, 23672, 23682, 23687, 23691, 23698, 23731, 23760, 23762, 23764, 23782, 23783, 23788, 23796, 23804, 23823, 23834, 23839, 23883, 23885, 23902, 23904, 23913, 23919, 23932, 23943, 23950, 23956, 23984, 23986, 23987, 23994, 23997, 23999, 24017, 24019, 24022, 24030, 24043, 24071, 24099, 24104, and 24107.
Why it was recalled
Magnet Quench, unintended- magnet of a mobile MRI system quenched into the exam room.
Root cause (FDA determination)
Device Design
Action the firm took
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.
Recalling firm
- Firm
- Siemens Medical Solutions USA, Inc
- Address
- 51 Valley Stream Pkwy, Malvern, Pennsylvania 19355-1406
Distribution
- Distribution pattern
- Nationwide Distribution
Timeline
- Recall initiated
- 2007-12-01
- Posted by FDA
- 2008-03-25
- Terminated
- 2012-10-01
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #67977. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.