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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens MAGNETOM MRI Systems with superconducting magnets

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  Class 2 Device Recall Siemens MAGNETOM MRI Systems with superconducting magnets see related information
Date Initiated by Firm December 07, 2015
Date Posted December 22, 2015
Recall Status1 Terminated 3 on June 21, 2017
Recall Number Z-0467-2016
Recall Event ID 72861
510(K)Number K133226  K132951  K002179  K032428  K130885  
Product Classification System, nuclear magnetic resonance imaging - Product Code LNH
Product MAGNETOM systems, magnetic resonance diagnostic devices (MRDD).
Code Information all units distributed since 1991
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355-1418
For Additional Information Contact
800-888-7436
Manufacturer Reason
for Recall		 Possible installation error of the quench lines of superconducting magnets, used to vent helium gas in the rare event of a quench. Any restriction, obstruction, or improper installation of the quench line may cause the helium gas to be blown directly into the magnet room or other areas. This could lead to displacement of oxygen, cause cold burns, and/or pose a risk to users, patient or others.
FDA Determined
Cause 2		 Other
Action Siemens sent an Customer Advisory letter dated December 7, 2015, certified mail to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter notifies customers of the potential injuries, which may result of improperly installed quench lines. The letter indicates it is the system's owner who is responsible for installing the quench line per the requirements. If Siemens installed the quench lines, the consignee is directed to contact Siemens, who will inspect the quench lines during next maintenance visit. Siemens will monitor service reports for affected sites. For further questions please call ( 610) 219-6300.
Quantity in Commerce in US 3752 units
Distribution Nationwide including : DC, PR, Virgin Islands and Bermuda
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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