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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 Recall
Magnetom Harmony syngo
see related information
Date Posted March 25, 2008
Recall Status1 Open
Recall Number Z-1044-2008
Recall Event ID 46245
Premarket Notification
510(K) Number
K970852 
Product Classification System, Nuclear Magnetic Resonance Imaging - 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, Pennsylvania 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
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 10 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.
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