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U.S. Department of Health and Human Services

Class 2 Device Recall Magnetom Espree System with OR Table

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  Class 2 Device Recall Magnetom Espree System with OR Table see related information
Date Initiated by Firm March 30, 2007
Date Posted April 26, 2007
Recall Status1 Terminated 3 on August 07, 2007
Recall Number Z-0769-2007
Recall Event ID 37760
510(K)Number K041112  
Product Classification magnetic resonance imaging system with OR table - Product Code LNH
Product Magnetom Espree System with OR Table
Code Information Model number 10092082, serial number 1002, 1003, and 1004.
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355-1406
For Additional Information Contact Roland Richter
610-448-1777
Manufacturer Reason
for Recall		 If table top is not seated properly it can lock up/stick.
FDA Determined
Cause 2		 Other
Action The recalling firm issued a Safety Advisory Letter to their customers on March 30, 2007, informing them of the problem and steps to take to avoid the problem.
Quantity in Commerce 3 units
Distribution The product was shipped to medical facilities in NY and TX.
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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