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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens MAGNETOM Aera magnetic resonance system

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 Class 2 Device Recall Siemens MAGNETOM Aera magnetic resonance systemsee related information
Date Initiated by FirmApril 24, 2014
Date PostedMay 27, 2014
Recall Status1 Terminated 3 on January 08, 2015
Recall NumberZ-1663-2014
Recall Event ID 68221
510(K)NumberK111242 
Product Classification System, nuclear magnetic resonance imaging - Product Code LNH
ProductMAGNETOM Aera magnetic resonance system. Indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that displays the internal structure and/or function of the head, body, or extremities.
Code Information model # 10432914 with serial numbers: 52126 52135 52108 52025 52101 
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355
For Additional Information ContactCustomer Support
610-219-6300
Manufacturer Reason
for Recall		Siemens discovered a processing error for the MAGNETOM Aera magnetic resonance system that may have resulted in some users not receiving Operator Manuals.
FDA Determined
Cause 2		Labeling design
ActionA customer safety advisory notice, dated April 24, 2014 was sent to notify direct accounts of the delivery of user manuals.
Quantity in Commerce5
DistributionDistributed in the states of MN, CA, CO, TX, and IA.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = LNH
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