FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Siemens Magnetom Symphony syngo, Model Number: 7104594, Siemens Medical Solutions USA, Malvern PA, 19355
- Recall number
- Z-1047-2008
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Siemens Magnetom Symphony syngo, Model Number: 7104594, Siemens Medical Solutions USA, Malvern PA, 19355
- Status
- Terminated
- Initiated
- 2007-12-01
- Posted
- 2008-03-25
- Terminated
- 2012-10-01
- Reason
- Magnet Quench, unintended- magnet of a mobile MRI system quenched into the exam room.
- Root cause
- Device Design
- Action
- 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.
- Quantity
- 141 units
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K970852"]
- PMA numbers
- not on file
- Product code
- LNH
- Firm FEI
- 2240869
- Firm city
- Malvern
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28