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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 Device Recall MAGNETOM Aera/Skyra see related information
Date Initiated by Firm April 13, 2016
Date Posted May 03, 2016
Recall Status1 Terminated 3 on April 17, 2017
Recall Number Z-1598-2016
Recall Event ID 73947
510(K)Number K101347  
Product Classification System, nuclear magnetic resonance imaging - Product Code LNH
Product MAGNETOM Aera/Skyra Systems, whole body magnetic resonance imaging systems, Model numbers 10432914, 10432915. Docking station top cover (part no# 10591430) of the removable patient table.
Code Information Model # 10432914 and 10432915 Serial Numbers: 42472, 42489, 42477, 46169, 46178, 46175, 42478, 42485
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355-1418
For Additional Information Contact Meredith Adams
610-448-3237
Manufacturer Reason
for Recall		 The docking station top cover of the removable patient table may contain a magnetic metal plate. When docking/undocking the table, the magnetic top cover may become attracted to the magnet.
FDA Determined
Cause 2		 Vendor change control
Action Siemens mailed to customers on April 13, 2016, a Customer Safety Advisory Notice, MR013/16/S, to inform them of the actions to take to prevent a possible hazard to persons and equipment. Customers were informed that they will be contacted by one of Siemens' service organization who will schedule an appointment to perform a correction, which is to exchange the top cover.
Quantity in Commerce 8 systems
Distribution US nationwide distribution to OH, FL, TN, MN, OH, NY, VA, and MN.
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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