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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-1048-2008
Recall Event ID 46245
510(K)NumberK970852 
Product Classification Nuclear Magnetic Resonance Imaging System - Product Code LNH
ProductSiemens Magentom Symphony syngo Upgrade, Model Number: 7106557, Siemens Medical Solutions USA, Malvern PA, 19355
Code Information Serial Numbers: 14001, 14087, 14101, 14182, 14184, 14186, 14206, 14220, 14235, 14236, 14238, 14247, 14252, 14264, 14272, 14276, 14278, 14312, 14334, 14344, 14357, 14359, 14360, 14362, 14268, 14427, 14424, 14427, 14430, 14431, 14434, 14436, 14438, 14443, and 14447.
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 Commerce35 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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