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U.S. Department of Health and Human Services

Class 2 Device Recall Magnetom Symphony syngo

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 Class 2 Device Recall Magnetom Symphony syngosee related information
Date Initiated by FirmDecember 01, 2007
Date PostedMarch 25, 2008
Recall Status1 Terminated 3 on October 01, 2012
Recall NumberZ-1047-2008
Recall Event ID 46245
510(K)NumberK970852 
Product Classification Nuclear Magnetic Resonance Imaging System - Product Code LNH
ProductSiemens Magnetom Symphony syngo, Model Number: 7104594, Siemens Medical Solutions USA, Malvern PA, 19355
Code Information 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.
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355-1406
For Additional Information ContactCatherine Moffa
610-448-4500
Manufacturer Reason
for Recall		Magnet Quench, unintended- magnet of a mobile MRI system quenched into the exam room.
FDA Determined
Cause 2		Device Design
ActionThe 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 in Commerce141 units
DistributionNationwide Distribution
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = LNH
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