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U.S. Department of Health and Human Services

Class 2 Device Recall MAGNETOM Aera/Skyra

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 Class 2 Recall
MAGNETOM Aera/Skyra
see related information
Date Posted August 10, 2011
Recall Status1 Terminated on January 14, 2014
Recall Number Z-2979-2011
Recall Event ID 59170
Premarket Notification
510(K) Number
K101347 
Product Classification System, Nuclear Magnetic Resonance Imaging - Product Code LNH
Product MAGNETOM Aera/Skyra System - Nuclear magnetic resonance imaging
Code Information Model numbers 10432914 and 10432915
Recalling Firm/
Manufacturer
Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern, Pennsylvania 19355
For Additional Information Contact Meredith Adams
610-219-6300
Manufacturer Reason
for Recall
Firm discovered during product monitoring that on a few systems the gradient cable connections did not meet their specifications after installation. Locally, the cable connections overheated, making servicing necessary.The potential exists for a cable connection to become overheated, leading to the emission of smoke and possible material damage.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action Siemens sent a "CUSTOMER SAFETY ADVISORY NOTICE" letter dated June 20, 2011 to all affected customers. The letter describes the product, problem, and actions that will be taken. The letter informs customers that an inspection of the gradient cable connections and an emergency shutdown mechanism will be installed by a field service representative during a visit to all affected locations.
Quantity in Commerce 26
Distribution Nationwide Distribution-USA (nationwide) including the states of AK, FL, GA, IL, MA, MI, MN, MT, NC, NJ, NY, OH, TX, UT, VA, WA, and WV.
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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