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U.S. Department of Health and Human Services

Class 2 Device Recall MAGNETOM Skyra

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  Class 2 Device Recall MAGNETOM Skyra see related information
Date Initiated by Firm July 09, 2019
Create Date August 22, 2019
Recall Status1 Terminated 3 on April 23, 2020
Recall Number Z-2343-2019
Recall Event ID 83415
510(K)Number K111242  
Product Classification System, nuclear magnetic resonance imaging - Product Code LNH
Product MAGNETOM Skyra magnetic resonance diagnostic devices
Model # 10432915
Code Information Serial # 46066 45732 46182 45735 45805 46171 45693 45886 45988 45881 46144 46044 46176 46179 46032 46238 145161 46127 45774 45968 46196 46175 45681 46007 46021 46105 46142 45928 45815 46150 145302 45878 46239 46026 145403 45667 145536 45970 45839 45982 46145 46298 45777 46294 
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355-1418
For Additional Information Contact Meredith Adams
610-219-4834
Manufacturer Reason
for Recall		 Potential of an open port in the quench venting system when using the optional horizontal outlet on the quench line assembly.
FDA Determined
Cause 2		 Device Design
Action 1. review the System Owner Manual chapter 1.3.3 Quench emergency plan and the section regarding defective vent line. 2. follow the standard emergency procedures you have in place in the event of system failures. 3.A Siemens Service Technician will conduct an inspection to verify that your system has a vertical outlet. If a vertical outlet is present, no further action is required. In the event your system is equipped with a horizontal outlet, the Siemens Service Technician will ensure that the port for the drop-off plate is adequately blanked off or sealed. 4.service organization will contact you shortly to arrange a date to perform this corrective action. Please feel free to contact our service organization for an earlier appointment at 1-800-888-7436. 5. Please review, understand, and confirm acknowledgement of the information and instructions outlined in this Customer Safety Advisory Notice. By signing this document you are acknowledging that you have read and understand the content therein. If you have any question, please contact Meredith Adams, Telephone 610-448-6461 and E-Mail: Meredith.adams@siemens-healthineers.com
Quantity in Commerce 44
Distribution AL AR AZ CA CO CT DC DE FL GA GU IA ID IL IN KS KY LA MA MD ME MI MN MO MT NC NE NH NJ NY OH OK OR PA SC TN TX VA WA WI WV WY
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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