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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 Tablesee related information
Date Initiated by FirmMarch 30, 2007
Date PostedApril 26, 2007
Recall Status1 Terminated 3 on August 07, 2007
Recall NumberZ-0769-2007
Recall Event ID 37760
510(K)NumberK041112 
Product Classification magnetic resonance imaging system with OR table - Product Code LNH
ProductMagnetom Espree System with OR Table
Code Information Model number 10092082, serial number 1002, 1003, and 1004.
FEI Number 2240869
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355-1406
For Additional Information ContactRoland 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
ActionThe 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 Commerce3 units
DistributionThe product was shipped to medical facilities in NY and TX.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = LNH
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