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U.S. Department of Health and Human Services

Class 2 Device Recall Combi Dockable Neurosurgery table for the Siemens MAGNETOM Aera (1.5T) and Skyra (3T) MRI Systems

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  Class 2 Device Recall Combi Dockable Neurosurgery table for the Siemens MAGNETOM Aera (1.5T) and Skyra (3T) MRI Systems see related information
Date Initiated by Firm October 17, 2016
Create Date April 10, 2017
Recall Status1 Terminated 3 on October 24, 2017
Recall Number Z-1770-2017
Recall Event ID 76889
510(K)Number K101347  
Product Classification System, nuclear magnetic resonance imaging - Product Code LNH
Product Combi Dockable Neurosurgery table for the Siemens MAGNETOM Aera (1.5T) and Skyra (3T) MRI Systems
Code Information Model Number: 10684336, 10684337 Serial Number: 12811002 12811003 12811017 
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355-1418
For Additional Information Contact Meredith Adams
610-448-6461
Manufacturer Reason
for Recall		 Due to a potential manufacturing error, a rare possibility exists for a sudden drop in table height of the Combi Dockable Table Neurosurgery.
FDA Determined
Cause 2		 Software design (manufacturing process)
Action Siemens mailed an Customer Safety Advisory Notice on October 17, 2016, to all affected customers to inform them of the corrective action they plan to take to correct the issue. The notice also informed users of the possible risks to patients and how the corrective action will be implemented. For further questions, please call (610) 448-6461.
Quantity in Commerce 3 systems distributed in the U.S.
Distribution US Distribution to: DC and MD.
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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