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U.S. Department of Health and Human Services

Class 2 Device Recall Magnetom Harmony syngo

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  Class 2 Device Recall Magnetom Harmony 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-1044-2008
Recall Event ID 46245
510(K)Number K970852  
Product Classification Nuclear Magnetic Resonance Imaging System - Product Code LNH
Product Siemens Magnetom Harmony sygno. Model Number: 7104693, Siemens Medical Solutions USA, Malvern PA, 19355
Code Information Serial Numbers: 11006, 11044, 11065, 11090, 11102, 11112, 11115, 11127, 11157, and 11162.
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 10 units
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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