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Class 2 Device Recall Magnetom Symphony syngo |
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Date Initiated by Firm |
December 01, 2007 |
Date Posted |
March 25, 2008 |
Recall Status1 |
Terminated 3 on October 01, 2012 |
Recall Number |
Z-1047-2008 |
Recall Event ID |
46245 |
510(K)Number |
K970852
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Product Classification |
Nuclear Magnetic Resonance Imaging System - Product Code LNH
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Product |
Siemens 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
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For Additional Information Contact |
Catherine Moffa 610-448-4500
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Manufacturer Reason for Recall |
Magnet Quench, unintended- magnet of a mobile MRI system quenched into the exam room.
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FDA Determined Cause 2 |
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 in Commerce |
141 units |
Distribution |
Nationwide Distribution |
Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = LNH and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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