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U.S. Department of Health and Human Services

Class 2 Device Recall Magnetom Sonata syngo

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  Class 2 Device Recall Magnetom Sonata syngo see related information
Date Initiated by Firm December 01, 2007
Date Posted March 25, 2008
Recall Status1 Terminated 3 on October 01, 2012
Recall Number Z-1046-2008
Recall Event ID 46245
510(K)Number K971684  
Product Classification Nuclear Magnetic Resonance Imaging System - Product Code LNH
Product Siemens Magnetom Sonata syngo, Model Number: 7106425, Siemens Medical Solutions USA, Malvern PA, 19355
Code Information Serial Number: 21936
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355-1406
For Additional Information Contact Catherine 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
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 1 unit
Distribution Nationwide Distribution
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = LNH and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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