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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 Recall
Magnetom Sonata syngo
see related information
Date Posted March 25, 2008
Recall Status1 Open
Recall Number Z-1049-2008
Recall Event ID 46245
Premarket Notification
510(K) Number
Product Classification System, Nuclear Magnetic Resonance Imaging - Product Code LNH
Product Siemens Magnetom Sonata syngo, Model Number: 7104719, Siemens Medical Solutions USA, Malvern PA, 19355
Code Information Serial Numbers: 21238 and 21269
Recalling Firm/
Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern, Pennsylvania 19355-1406
For Additional Information Contact Catherine Moffa
Manufacturer Reason
for Recall
Magnet Quench, unintended- magnet of a mobile MRI system quenched into the exam room.
FDA Determined
Cause 2
DESIGN: Software 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 2 units
Distribution Nationwide Distribution
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LNH and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.